FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1040679
·
Received May 8, 2008
Report
- Report Number
- 1826988-2008-00488
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- April 15, 2008
- Report Date
- April 15, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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 330 MG/DL HIGH , OUT OF SPEC. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.
Description of Event or Problem · 1
THE CUSTOMER CALLED AND ALLEGED THAT HE RECEIVED SOME CONTROL TEST RESULTS THAT WERE HIGH, OUT OF SPECIFICATION. TROUBLESHOOTING, SHOWED THE TEST STRIPS TO BE OPERATING AS DESIGNED, BUT THE TEST STRIPS WERE RETURNED FOR EVALUATION BASED ON THE CUSTOMER'S ALLEGATIONS. 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 | 7080D | 7DC3D04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |