FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1518578
·
Received October 28, 2009
Report
- Report Number
- 2531779-2009-00531
- Event Type
- Injury
- Date Received
- October 28, 2009
- Date of Event
- August 22, 2009
- Report Date
- October 2, 2009
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. A REVIEW OF THE PUP HISTORY INDICATED THAT THE PUMP EMITTED AN EMPTY CARTRIDGE ALARM, AFTER WHICH PUMP INSULIN DELIVERY WAS MANUALLY SUSPENDED BY THE USER. THE HISTORY ALSO INDICATED THAT INSULIN DELIVERY WAS NOT RESUMED. EVALUATION DEMONSTRATED THAT THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERY ACCURACY, AND THE PUMP WAS CONFIRMED TO PROPERLY EMIT BOTH VISUAL AND AUDIBLE ALARM NOTIFICATIONS.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THAT THE PT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS, DKA, CARDIAC ARREST, AND COMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |