FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1802538
·
Received August 9, 2010
Report
- Report Number
- 2531779-2010-00899
- Event Type
- Injury
- Date Received
- August 9, 2010
- Date of Event
- July 15, 2010
- Report Date
- July 15, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED AN EVAL WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE PT WAS UNAWARE THAT MAXIMUM LIMITS COULD BE SET ON INSULIN DOSES AND REPORTED THAT HE EXCEEDED THE INSULIN LIMITS. PUMP SETTINGS AND INSULIN DELIVERY HISTORY WERE REVIEWED WITH THE PATIENT AND CONFIRMED AS ACCURATE. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS TREATED AT THE EMERGENCY ROOM FOR ELEVATED BLOOD GLUCOSE LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | IR 1250 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization |