FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 1031905
·
Received April 15, 2008
Report
- Report Number
- 1826988-2008-00410
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- April 4, 2008
- Report Date
- April 4, 2008
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 216 MG/DL HIGH, OUT OF SPEC. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.
Description of Event or Problem · 1
THE CUSTOMER CALLED FOR HELP WITH HIS METER. HIS INITIAL COMPLAINT DID NOT MEET THE CRITERIA TO BE REPORTED. THE CUSTOMER'S TEST STRIPS WERE RETURNED FOR EVAL. 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 | 6LC3C07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |