FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1425213
·
Received April 22, 2009
Report
- Report Number
- 1826988-2009-00326
- Event Type
- Malfunction
- Date Received
- April 22, 2009
- Date of Event
- April 9, 2009
- Report Date
- April 9, 2009
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE QA LAB FOUND THE RETUNED REAGENT TO READ AN AVERAGE OF 61 MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT HE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 247 MG/DL. HE PERFORMED CONTROL TESTS WHILE TROUBLESHOOTING AND THE RESULTS FELL WITHIN THE NORMAL CONTROL RANGE OF 102-143 MG/DL, SO THE COMPLAINT WAS NOT INITIALLY REPORTED. THE 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 | 7080G | 8BC3D12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |