FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TEST STRIPS (50)
MDR report key: 999825
·
Received February 13, 2008
Report
- Report Number
- 1826988-2008-00177
- Event Type
- Malfunction
- Date Received
- February 13, 2008
- Date of Event
- January 14, 2008
- Report Date
- January 14, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE QA LAB FOUND THE RETURNED REAGENT TO READ AN AVERAGE OF 313MG/DL HIGH, OUT OF SPEC. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. SHE DID NOT ALLEGE ANY ADVERSE EVENTS BASED ON THE HIGHER READINGS. THE CUSTOMER'S 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 | 7098B | 7CC3B02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |