FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1822824
·
Received August 30, 2010
Report
- Report Number
- 2531779-2010-01121
- Event Type
- Injury
- Date Received
- August 30, 2010
- Date of Event
- July 30, 2010
- Report Date
- July 30, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE PT'S PHYSICIAN BELIEVES THAT THE PT'S BASAL RATES ARE TOO HIGH. THE PHYSICIAN HAS RECOMMENDED LOWERING THE BASAL RATES. THE NURSE LOWERED THE PT'S BASAL RATES PER THE PHYSICIAN RECOMMENDATION, AND THE PT HAS CONTINUED TO USE THE PUMP WITH NO ISSUES. 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 THE PT WAS TREATED IN THE EMERGENCY DEPT OF (B)(6) MEDICAL CENTER FOR HYPOGLYCEMIA.
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 | 60 YR | Required Intervention |