FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1911918
·
Received November 24, 2010
Report
- Report Number
- 2531779-2010-02540
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- October 27, 2010
- Report Date
- October 27, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED AN EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
THE PT REPORTED THAT THE "OK" BUTTON WAS NOT RESPONDING ON THE KEYPAD. THE REPORTER DENIES DAMAGE TO THE KEYPAD OR EXPOSURE TO MOISTURE AND CLEANING SOLVENTS.
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 | 13 YR |