FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1378664
·
Received February 20, 2009
Report
- Report Number
- 1826988-2009-00112
- Event Type
- Malfunction
- Date Received
- February 20, 2009
- Date of Event
- February 3, 2009
- Report Date
- February 3, 2009
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE QA LAB FOUND THE RETURNED REAGENT TO READ E11 (CONFIRMS EXPOSURE) AND AN AVERAGE OF 199 MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT HIS BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. HIS INITIAL COMPLAINT DID NOT MEET THE CRITERIA TO BE REPORTED, BUT HIS TEST STRIPS WERE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR TEST STRIPS (50) | BLOOD GLUCOSE TEST STRIPS | NBW | BAYER HEALTHCARE, LLC | 7098B | 8AC3C03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |