FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TS TEST STRIPS (50)
MDR report key: 1212750
·
Received October 20, 2008
Report
- Report Number
- 1826988-2008-01200
- Event Type
- Malfunction
- Date Received
- October 20, 2008
- Date of Event
- October 8, 2008
- Report Date
- October 8, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE QA LAB FOUND THE RETURNED REAGENT TO READ ELL (CONFIRMS EXPOSURE) AND AN AVERAGE OF 299 MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT HE HAD RECEIVED HIGH BLOOD GLUCOSE AND CONTROL TEST RESULTS. HIS INITIAL COMPLAINT DID NOT MEET THE CRITERIA TO BE REPORTED, BUT HIS 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 TS TEST STRIPS (50) | BLOOD GLUCOSE TEST STRIPS | NBW | BAYER HEALTHCARE, LLC | 1858 | 7LD3E07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |