OT VERIO PRO METER
Report
- Report Number
- 3008382007-2012-03162
- Event Type
- Malfunction
- Date Received
- July 17, 2012
- Report Date
- July 9, 2012
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
THE METER AND TEST STRIPS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. LIFESCAN (LFS) RECEIVED THE TEST STRIPS INVOLVED WITH THIS COMPLAINT ON (B)(4) 2012; HOWEVER THE INVESTIGATION HAS NOT BEEN COMPLETED. IF THE METER IS RETURNED, LFS WILL EVALUATE THE METER AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LFS CONSIDERS THIS MATTER CLOSED.
FOLLOW-UP (9/10/2012)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. 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) 2012, THE LAY USER/ PATIENT'S WIFE CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE ONETOUCH VERIO PRO METER READ INACCURATELY ERRATIC. THE PATIENT'S WIFE REPORTED BLOOD GLUCOSE RESULTS OF "153, 105, 540, AND 63 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT'S WIFE STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. AS THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING, THIS COMPLAINT IS BEING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT VERIO PRO METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 112 YR |