FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1032085
·
Received April 18, 2008
Report
- Report Number
- 1826988-2008-00483
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 1, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE QA LAB FOUND THE RETURNED REAGENT TO READ AN AVERAGE OF 15 MG/DL HIGH, OUT OF SPEC.
Description of Event or Problem · 1
A CUSTOMER IN THE UK STATED THAT HE OPENED A NEW CARTON OF TEST STRIPS AND FOUND THE CAP OPEN ON THE BOTTLE OF STRIPS. 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 | NOT PROVIDED | 7JC3B04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |