FDA Adverse Event
Malfunction
Summary report: N
ASCENSIA BREEZE (US)
MDR report key: 1181987
·
Received September 26, 2008
Report
- Report Number
- 1826988-2008-01048
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- August 29, 2008
- Report Date
- August 29, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER CALLED FOR HELP WITH HER BREEZE METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 46 MG/DL. THE NORMAL CONTROL RANGE WAS 113-162 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. CUSTOMER SERVICE CONTACTED THE CUSTOMER AFTER THE INITIAL CALL ABOUT RETURNING HER TEST STRIPS, BUT SHE HAD ALREADY DISPOSED OF THEM. NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSIA BREEZE (US) | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE, LLC | 6117 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |