ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-13693
- Event Type
- Malfunction
- Date Received
- May 15, 2014
- Report Date
- May 8, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
FOLLOW-UP #1: DATE OF SUBMISSION 06/23/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/06/2016 WITH THE FOLLOWING FINDINGS: BLACK BOX SHOWS DATES FROM (B)(4) 2016, (B)(4) 2007. BLACK BOX DATA FROM DATE OF COMPLAINT HAS BEEN OVERWRITTEN. UNABLE TO CONFIRM OR DUPLICATE COMPLAINT DURING INVESTIGATION. NO BATTERY CAP OR CARTRIDGE CAP WAS RETURNED. ALL TESTING PERFORMED WITH TEST CAPS. THE BATTERY CAP IS ABLE TO FULLY TIGHTEN. CURRENT DRAWS ARE WITHIN SPECIFICATIONS A "BATTERY LIFE" ISSUE WAS NOT DUPLICATED DURING THE INVESTIGATION. REMOVED PUMP CASE AND DISASSEMBLED PUMP. NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS OBSERVED INSIDE PUMP. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.
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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) 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 |
|---|---|---|---|---|---|---|---|
| 291965 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |