FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2143264
·
Received June 28, 2011
Report
- Report Number
- 2531779-2011-04543
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Report Date
- June 2, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/23/2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS AND THE OK BUTTON CONTACT WAS MISALIGNED.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE OK BUTTON HAD A DELAYED RESPONSE OR WILL KEEP SCROLLING. THE PATIENT REPORTEDLY WORE THE PUMP IN A CASE ON HIS BELT AND DID NOT CLEAN THE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONETOUCH PING INSULIN PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |