FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3022795
·
Received March 27, 2013
Report
- Report Number
- 2531779-2013-03118
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Report Date
- February 28, 2013
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/28/2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY SCREEN WAS DIM/FADED AND SCRATCHED. UNRELATED TO THE COMPLAINT, THE PUMP CASE WAS FOUND TO BE CRACKED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM/FADED AND SCRATCHED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125840 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |