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FDA · FDA event 96230 · Posted Mar 5, 2025
Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision impairment.
The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.
| Model | Description | Lot / serial range | Manufactured | Status |
|---|---|---|---|---|
| Z-1270-2025 | Z-1270-2025 | Model Number: TM0009; UDI-DI: 00859519002407; Serial Numbers: Serial Numbers are formatted as TFXXXXXX or TGXXXXXX (X represents digits). Meter Serial Numbers: TF048802, TF098191, TF079123, TF076786, TF076836, TF089080, TF088984, TF086097, TF085390, TF085029, TF084238, TF098751, TF098975, TF098976, TF096704, TF096961, TF096966, TF117862, TF127077, TF049583, TF047153, TF063135, TF127267, TF100376, TF086287, TF104396, TF104399, TF104401, TF104403, TF104404, TF104405, TF104407, TF104408, TF104409, TF104410, TF104411, TF104412, TF104414, TF104415, TF104416, TF104417, TF104418, TF104421, TF104426, TF104427, TF104428, TF104429, TF104430, TF104431, TF104432, TF104433, TF104439, TF104440, TF104441, TF104442, TF104444, TF104446, TF104448, TF104449, TF104452, TF104453, TF104454, TF104455, TF104456, TF104458, TF104460, TF104461, TF104462, TF104467, TF104468, TF104469, TF104471, TF104473, TF104474, TF104479, TF104480, TF104481, TF104482, TF104483, TF104486, TF104487, TF104490, TF104491, TF104492, TF104494, TF104496, TF104498, TF104500, TF104501, TF104503, TF104505, TF104506, TF104510, TF104511, TF104512, TF104514, TF104516, TF104520, TF104521, TF104522, TF104525, TF104526, TF104527, TF104528, TF104529, TF104530, TF104534, TF104535, TF104537, TF104538, TF104541, TF104545, TF104554, TF104555, TF104566, TF104567, TF104568, TF104570, TF104571, TF104573, TF104576, TF104577, TF104579, TF104581, TF104585, TF104586, TF104588, TF104589, TF104590, TF104592, TF104593, TF104595, TF104599, TF104601, TF104602, TF104605, TF104609, TF104610, TF104615, TF104618, TF104620, TF104621, TF104625, TF104626, TF104628, TF104629, TF104630, TF104632, TF104634, TF104635, TF104639, TF104641, TF104642, TF104643, TF104644, TF104646, TF104652, TF104657, TF104660, TF104661, TF104662, TF104663, TF104664, TF104666, TF104667, TF104670, TF104673, TF104674, TF104676, TF104677, TF104680, TF104681, TF104684, TF104693, TF104694, TF104695, TF104697, TF104699, TF104716, TF104718, TF104721, TF104724, TF104725, TF104726, TF104727, TF104729, TF104733, TF104735, TF104739, TF104740, TF104742, TF104745, TF104746, TF104747, TF104749, TF104751, TF104753, TF104754, TF104760, TF104761, TF104762, TF104770, TF104771, TF104777, TF104782, TF104789, TF104790, TF104791, TF104794, TF104795, TF111281, TF111284, TF111290, TF111291, TF111292, TF111295, TF111297, TF111304, TF111305, TF111307, TF111310, TF111312, TF111317, TF111329, TF111330, TF111331, TF111334, TF111335, TF111344, TF111345, TF111346, TF111355, TF111356, TF111357, TF111359, TF111364, TF111366, TF111369, TF111370, TF111371, TF111375, TF111379, TF111380, TF111383, TF111388, TF111389, TF111390, TF111392, TF111393, TF111427, TF111438, TF111445, TF111448, TF111455, TF111458, TF111469, TF111471, TF111472, TF111486, TF111494, TF111498, TF111499, TF111500, TF111501, TF111503, TF111504, TF111516, TF111517, TF111519, TF111520, TF111524, TF111528, TF111530, TF111534, TF111536, TF111538, TF111539, TF111540, TF111542, TF111545, TF111548, TF111550, TF111597, TF111598, TF111599, TF111601, TF111603, TF111604, TF111606, TF111607, TF111609, TF111613, TF111616, TF111617, TF111619, TF111622, TF111624, TF111643, TF111644, TF111656, TF111681, TF111684, TF111689, TF111697, TF111698, TF111700, TF111701, TF111703, TF111705, TF111708, TF111709, TF111712, TF111713, TF111716, TF111717, TF111718, TF111723, TF111725, TF111726, TF111729, TF111730, TF111731, TF111733, TF111735, TF111737, TF111739, TF111741, TF111743, TF123096, TF011506, TG010678, TG003948, TF036405, TF059736, TF059853, TF049701, TF051924, TF068293, TF070926, TF074412, TF029171, TF026673, TF026674, TF026678, TF031651, TF031687, TF132974, TF104276, TF104316, TF096751, TF086252, TF093840, TF111145, TF020863, TF025950, TF026542, TF069228, TF028754, TF020418, TF113391, TF108704, TF108488, TF110620, TF119900, TF119724, TF117837, TF121255, TF120910, TF123738, TF123852, TF123915, TF131660, TF131207, TF127933, TF127452, TF127335, TF127402, TF102437, TF100298, TF004843, TF004981, TF005341, TF001824, TF001928.TF001513, TF001368, TF001370, TF001299, TF003332, TF003336, TF003531, TF003517, TF003511, TF003486, TF003495, TF003424, TF026397, TF042726, TF041960, TF041961, TF041988, TF041931, TF041947, TF041964, TF041966, TF041969, TF041971, TF041976, TF041834, TF041836, TF041838, TF041854, TF041908, TF041913, TF041915, TF041889, TF041894, TF041896, TF041899, TF041904, TF041905, TF041757, TF041798, TF041801, TF041804, TF041805, TF041816, TF041818, TF041785, TF041675, TF060745, TF059802, TF059540, TF049643, TF043061, TF043063, TF043074, TF043078, TF043079, TF043081, TF043082, TF043085, TF043098, TF043100, TF043102, TF043242, TF043244, TF043246, TF043228, TF043229, TF043108, TF043109, TF043214, TF043220, TF043222, TF043113, TF043114, TF043117, TF043121, TF043130, TF043131, TF043135, TF043136, TF043138, TF043149, TF043151, TF043155, TF043159, TF043160, TF043161, TF043164, TF043165, TF043170, TF043174, TF043176, TF043183, TF043186, TF043189… See the official FDA source for the complete identifier list. | Not provided in the normalized record | Ongoing |
Jan 30, 2025
Recall initiated
Date recorded by the FDA.
Mar 5, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.