ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2015-19615
- Event Type
- Malfunction
- Date Received
- June 12, 2015
- Report Date
- May 31, 2015
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
Narratives
FOLLOW-UP #1: DATE OF SUBMISSION 8/19/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/23/2015 WITH THE FOLLOWING FINDINGS: VISIBLE MOISTURE BEHIND THE DISPLAY LENS. LEAK TEST PERFORMED; FAILED DUE TO CRACKED PUMP CASE, AT THE CASE SEAL/TOP RIGHT CORNER. PUMP POWERS UP WITH AUDIO/VIBRATION; DISPLAY SCREEN IS BLANK. OPENED PUMP; EVIDENCE OF MOISTURE FOUND ON THE DISPLAY FLEX & DISPLAY CONNECTOR, INSIDE THE COVER, ON THE SUPPORT BRACKET AND ON THE FORCE SENSOR. UNABLE TO PERFORM/VERIFY ALL STEPS OF THIS INVESTIGATION DUE TO INTERNAL MOISTURE; DAMAGED DISPLAY A REVIEW OF THE BLACK BOX INDICATES MULTIPLE POWER ON RESETS OCCURRED; UNABLE TO DUPLICATE DURING THE INVESTIGATION. NO ALARMS IN THE BLACK BOX OR ALARM HISTORY RELATED TO THE COMPLAINT. RETURNED BATTERY CAP USED TO PERFORM INVESTIGATION.
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.
ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) 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 |
|---|---|---|---|---|---|---|---|
| 386191 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |