ONETOUCHPING GLUCOSEMGMTSYSTEM
Report
- Report Number
- 2531779-2014-26704
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Report Date
- September 6, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE PUMP BOOTS TO VERIFY SCREEN WITH VIBRATORY AND AUDIBLE FEATURES. AN EZPRIME SEQUENCE AND 24HR DURATION TEST WERE SUCCESSFULLY COMPLETED. THE TOTAL DAILY DOSE ADDS UP CORRECTLY. NO ERRORS, ALARMS OR WARNINGS RELATED TO THE COMPLAINT IN PUMP HISTORY. PUMP SUCCESSFULLY COMPLETED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN SPECIFICATION. PATIENT NEGLIGENCE ISSUE - PUMP SUBJECTED TO CONDITIONS OUTSIDE SPECIFICATION. THE PUMP IS NOT DETECTING THE CORRECT FORCE AT 5 POUNDS. REMOVED COVER AND DISASSEMBLED PUMP AND THE FORCE SENSOR RESISTANCE WAS FOUND TO BE IN SPECIFICATIONS. NO EVIDENCE OF CONTAMINATION FOUND IN FORCE SENSOR HOUSING. THE BATTERY COMPARTMENT IS CRACKED BETWEEN BUMPER GRIP AND CASE SEAL. RETURNED BATTERY CAP IS ABLE TO FULLY ATTACH TO THE PUMP AND USER USED TO COMPLETE ALL TESTING. (B)(6).
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT AND THE PUMP IS NOT DETECTING CORRECT FORCE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580158 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |