FDA Adverse Event
Malfunction
Summary report: N
CONTOUR USB
MDR report key: 2072603
·
Received April 25, 2011
Report
- Report Number
- 1826988-2011-00203
- Event Type
- Malfunction
- Date Received
- April 25, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 24, 2011
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- PMA / PMN Number
- K091820
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT CODE AND SERIAL NUMBER FOR THE OTHER METER: (B)(4); MANUFACTURE DATE: 01/2011.
Description of Event or Problem · 1
A (B)(6) CUSTOMER CALLED REGARDING 2 CONTOUR USB METERS THAT HE RECENTLY PURCHASED. BOTH METER WERE FOUND TO BE READING IN MG/DL. IT WAS DISCOVERED THAT BOTH METERS WERE INTENDED FOR THE U.S. MARKET. NO ADVERSE EVENTS WERE ALLEGED. THE METERS ARE TO BE RETURNED. REPLACEMENT METERS WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR USB | NBW | BAYER HEALTHCARE, LLC | 7393A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |