FDA Adverse Event
Malfunction
Summary report: N
CONTOUR
MDR report key: 2212075
·
Received July 8, 2011
Report
- Report Number
- 1826988-2011-00397
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 20, 2011
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CALL ENDED BEFORE THE CUSTOMER'S PERSONAL INFORMATION OR PRODUCT INFORMATION COULD BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE OR 510K NUMBER WITHOUT THE METER INFORMATION.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT HE PERFORMED A CONTROL TEST USING HIS CONTOUR SYSTEM AND RECEIVED A RESULT HIGHER THAN 300 MG/DL. THE NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 106-147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. NO PRODUCT WILL BE RETURNED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR | NBW | BAYER HEALTHCARE LLC | NOT PROVIDED | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |