FDA Adverse Event
Malfunction
Summary report: N
BREEZE2
MDR report key: 1518116
·
Received October 26, 2009
Report
- Report Number
- 1826988-2009-00945
- Event Type
- Malfunction
- Date Received
- October 26, 2009
- Date of Event
- October 15, 2009
- Report Date
- October 15, 2009
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER CONTOUR AND BREEZE2 METERS. THE CONTOUR METER READ IN THE 200'S (MG/DL), WHILE THE BREEZE2 METER READING IN THE 400'S (MG/DL). DEPENDING ON THE ACTUAL READINGS, THE DIFFERENT BETWEEN THEM FALL IN "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED THE OFFER TO TROUBLESHOOT HER BREEZE2 METER. NO PRODUCT WILL BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREEZE2 | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE, LLC | 1440 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |