Model Number 1000096 |
Device Problem
Failure to Power Up (1476)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/08/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.
|
|
Event Description
|
It was reported that the pump could not be powered on and remained unresponsive.Customer¿s blood glucose level was 78 mg/dl.The customer reverted to an alternate method of insulin therapy.
|
|
Manufacturer Narrative
|
The failure investigation has been completed.Based on the analysis, the alleged issue was verified and a different issue was identified.
|
|
Search Alerts/Recalls
|