FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1505991
·
Received September 16, 2009
Report
- Report Number
- 1826988-2009-00782
- Event Type
- Malfunction
- Date Received
- September 16, 2009
- Date of Event
- August 26, 2009
- Report Date
- August 26, 2009
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE QA LAB FOUND THE RETURNED REAGENT TO READ AN AVERAGE OF 127 MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.
Description of Event or Problem · 1
THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR METER. SHE RECEIVED A HIGH CONTROL RESULT WHILE TROUBLESHOOTING, BUT THE RESULT DID NOT MEET THE CRITERIA TO BE REPORTED. THE CUSTOMER RETURNED HER TESTS STRIPS 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 | 7080G | 8JC3D07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |