FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1477482
·
Received July 10, 2009
Report
- Report Number
- 1826988-2009-00601
- Event Type
- Malfunction
- Date Received
- July 10, 2009
- Date of Event
- June 25, 2009
- Report Date
- June 25, 2009
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE QA LAB FOUND THE RETURNED REAGENT TO READ E11 AND 375 MG/DL HIGH, OUT OF SPEC. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.
Description of Event or Problem · 1
THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR METER. HER INITIAL COMPLAINT DID NOT MEET THE CRITERIA TO BE REPORTED, BUT HER TEST STRIPS WERE RETURNED FOR EVAL. 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 | 7080G | 8JC3D07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |