FDA Adverse Event
Malfunction
Summary report: N
BREEZE2
MDR report key: 1982550
·
Received January 11, 2011
Report
- Report Number
- 1826988-2010-00874
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 17, 2010
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- PMA / PMN Number
- K062347
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS BREEZE2 METER AND RECEIVED READINGS OF 252 AND 183 MG/DL. HE RETESTED USING ANOTHER METER AND RECEIVED READINGS OF 97 AND 67 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. CONTROL SOLUTION WAS SENT FOR FURTHER TROUBLESHOOTING. THE CUSTOMER'S METER WAS ALSO REPLACED. NO PRODUCT WILL BE RETURNED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREEZE2 | NBW | BAYER HEALTHCARE, LLC | 1440 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |