ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-17502
- Event Type
- Malfunction
- Date Received
- June 18, 2014
- Report Date
- June 15, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
(B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/14/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. MOISTURE AND CORROSION WERE OBSERVED IN THE DISPLAY AND INFRARED COMMUNICATION PORT. A LEAK TEST SHOWED A LEAK AT THE DISPLAY LENS. THE PUMP POWERED UP WITH THE APPROPRIATE AUDIBLE AND VIBRATORY FEATURES. THE DISPLAY SCREEN WAS DIM AND MULTI-COLORED. THE KEYPAD BUTTONS WERE NOT RESPONDING TO USER INPUT. THE INVESTIGATION WAS UNABLE TO COMPLETE THE REMAINING TESTING. THE PUMP CASING WAS OPENED AND MOISTURE CORROSION WAS FOUND THROUGHOUT THE PUMP INTERIOR.
ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. REPORTEDLY, THE DISPLAY WAS DIM AND MOISTURE WAS OBSERVED IN THE BATTERY COMPARTMENT. IT WAS NOTED THAT PUMP REBOOT DID NOT RESOLVE THE DISPLAY ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358321 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |