FDA Adverse Event
Malfunction
Summary report: N
BREEZE2
MDR report key: 2870563
·
Received December 12, 2012
Report
- Report Number
- 1826988-2012-00646
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 19, 2012
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- PMA / PMN Number
- K062347
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE METER WAS RECEIVED AND EVALUATED BY QA. IT WAS CONFIRMED TO HAVE A CRACKED DISPLAY AND SEGMENTS WERE MISSING IN ALL POSITIONS.
Additional Manufacturer Narrative · 1
THE INITIAL REPORTER INFORMATION WAS NOT PROVIDED.
Additional Manufacturer Narrative · 1
THE INITIAL REPORTER INFORMATION WAS NOT PROVIDED.
Description of Event or Problem · 1
THE ADVOCATE STATED THE CUSTOMER'S METER WAS MISSING SEGMENTS AND THE CUSTOMER WAS UNAWARE OF IT. NO ADVERSE EVENTS WERE ALLEGED. SEGMENTS A, B, C, D, E, F AND G APPEARED TO BE MISSING FROM THE UNITS, TENS AND HUNDRED'S POSITIONS. THE TIME/DATE AREA WAS MISSING SEGMENTS AS WELL. THE METER WAS REPLACED AND THE CUSTOMER IS EXPECTED TO RETURN HIS METER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREEZE2 | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE LLC | 9570A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |