FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2822151
·
Received November 7, 2012
Report
- Report Number
- 2531779-2012-13228
- Event Type
- Malfunction
- Date Received
- November 7, 2012
- Report Date
- September 24, 2012
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS INTACT AND ALL KEYS RESPONSIVE. REMOVED KEYPAD AND CONTAMINATION WAS NOTED UNDER "CONTRAST" AND "UP" KEY CONTACTS. THE BATTERY COMPARTMENT WAS CRACKED, BUT THE PUMP POWERED WITH THE RETURNED BATTERY CAP.
Description of Event or Problem · 1
THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED CONTAMINATION UNDER KEYPAD CONTACTS AND A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON (B)(4) 2012.
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 | 13 YR |