FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1820626
·
Received August 26, 2010
Report
- Report Number
- 2531779-2010-01101
- Event Type
- Injury
- Date Received
- August 26, 2010
- Date of Event
- July 18, 2010
- Report Date
- July 26, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PT REPORTED THE HYPOGLYCEMIA WAS RESOLVED WITHOUT THE NEED FOR MEDICAL INTERVENTION. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL AT THIS TIME. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
THE PT REPORTED LOW BLOOD GLUCOSE EPISODE (28 MG/DL) THAT WAS SELF-TREATED WITH ORAL CARBOHYDRATES. IT WAS REPORTED THAT THE PUMP DISPENSED INSULIN WITHOUT USER INTERVENTION.
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 | 57 YR | Required Intervention |