FDA Recalls Faulty Insulin Pump App After Hundreds Injured
Over 224 diabetes patients suffered due to a software glitch in Tandem Diabetes Care's t:connect app, prompting an urgent recall.
- The t:connect app issue led to unexpected insulin pump shutdowns, risking severe hyperglycemia and ketoacidosis.
- FDA classified the recall as Class I, indicating a risk of serious injury or death.
- Affected users are urged to update their app to version 2.7.1 to prevent further incidents.
- No fatalities have been reported, but the software flaw has caused significant concern among patients.
- Tandem Diabetes Care has issued urgent updates and instructions to mitigate the risk to users.