FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1822845
·
Received August 30, 2010
Report
- Report Number
- 2531779-2010-01128
- Event Type
- Injury
- Date Received
- August 30, 2010
- Date of Event
- July 28, 2010
- Report Date
- July 28, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE PT WAS ON A BACK UP PLAN FOR INSULIN DELIVERY AT THE TIME OF HOSPITAL ADMISSION. PRIOR TO DISCHARGE, THE PHYSICIAN RECOMMENDED CHANGES TO THE PUMP SETTINGS. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT WAS HOSPITALIZED FOR DKA. THE PT WAS ON BACK UP PLAN ON THE DAY OF HOSPITALIZATION. INSULIN PUMP THERAPY WAS DISCONTINUED WHEN BATTERY CAP WOULD NOT SECURE TO THE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Hospitalization |