FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2143267
·
Received June 28, 2011
Report
- Report Number
- 2531779-2011-04544
- 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
- LA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE BUTTONS ARE NOT ALWAYS RESPONDING TO PRESSES. THE PATIENT REPORTEDLY WORE THE PUMP IN A CASE ON HER 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 | 37 YR |