OT PING METER
Report
- Report Number
- 3008382007-2013-17388
- Event Type
- Malfunction
- Date Received
- June 15, 2013
- Report Date
- June 12, 2013
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- PMA / PMN Number
- K082590
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
FOLLOW-UP # 1 ¿ (07/22/2013). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/25/2013 AND 7/15/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, SEVERAL ISSUES WAS NOTED. FIRSTLY, ERROR 4 AND 5 WAS OBSERVED DURING CONTROL SOLUTION TESTS. SECONDLY, THE ENZYME ON THE TEST STRIPS WAS CONTAMINATED WITH AN UNKNOWN SUBSTANCE. AND THIRDLY, IT WAS FOUND THAT THE RETURNED TEST STRIPS, WHEN TESTED WITH CONTROL SOLUTION, GAVE RESULTS GREATER THAN +50% OF THE CONTROL SOLUTION RANGE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.
ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING AN 'ERROR 2' STRIP 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. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272425 | OT PING METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3444189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |