FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1923917
·
Received December 13, 2010
Report
- Report Number
- 2531779-2010-02833
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Report Date
- November 12, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. THE EVAL OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
THE REPORTER CONTACTED ANIMAS ON BEHALF OF HIS SON (THE PT) ALLEGING A LOSS OF PRIME ISSUE WITH THE PUMP. THROUGH ANALYSIS, THE ANIMAS CDE NOTED THAT THE PUMP HAD A SPONTANEOUS BATTERY NOTIFICATION SCREEN. NO DAMAGE WAS NOTED IN REGARDS TO THE BATTERY CAP. THE BATTERY CAP AND PUMP WERE REPORTEDLY NEW. NO CRACKS WERE NOTED NEAR THE BATTERY COMPARTMENT. IN ADDITION, THE YELLOW O-RING WAS NOT VISIBLE AND THE BATTERY CAP COULD NOT BE TIGHTENED FURTHER. NO STRIPPED THREADS WERE OBSERVED ON THE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ONE TOUCH PING | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |