FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1030592
·
Received April 15, 2008
Report
- Report Number
- 1826988-2008-00377
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 19, 2008
- Report Date
- March 19, 2008
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE QA LAB FOUND THE RETURNED REAGENT TO READ AN AVERAGE OF 39MG/DL HIGH, OUT OF SPEC. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT HE OPENED A NEW CARTON CONTAINING 2 BOTTLES OF TEST STRIPS AND FOUND THE CAP OPEN ON ONE OF THE BOTTLES. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT THE TEST STRIPS BECAUSE HIS CONTROL SOLUTION WAS EXPIRED. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE RETURNED FOR EVAL, AS EXPOSURE TO MOISTURE CAN CAUSE HIGH TEST RESULTS. 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 | 7CC3B01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |