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100 results
FDA · FDA event 96628
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Posted May 7, 2025
FDA · FDA event 96624
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Posted May 5, 2025
FDA · FDA event 96417
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at…
Posted Apr 11, 2025
FDA · FDA event 96323
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Posted Mar 13, 2025
FDA · FDA event 96289
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
Posted Mar 6, 2025
FDA · FDA event 96230
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) -…
Posted Mar 5, 2025
FDA · FDA event 96200
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected…
Posted Mar 3, 2025
FDA · FDA event 96136
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume,…
Posted Feb 26, 2025
FDA · FDA event 96069
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.
Posted Feb 24, 2025
FDA · FDA event 96091
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be…
Posted Feb 20, 2025