FDA Adverse Event
Malfunction
Summary report: N
ASCENSIA BREEZE2 TEST STRIPS (100)
MDR report key: 1060962
·
Received June 13, 2008
Report
- Report Number
- 1826988-2008-00617
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 14, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE QA LAB RECEIVED AN EMPTY DISC, SO FURTHER TESTING WAS NOT POSSIBLE.
Description of Event or Problem · 1
THE CUSTOMER CALLED FOR HELP WITH HER BREEZE2 METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 511 MG/DL. THE NORMAL CONTROL RANGE WAS 89-121 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER'S REMAINING DISC WAS RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSIA BREEZE2 TEST STRIPS (100) | BLOOD GLUCOSE TEST STRIPS | NBW | BAYER HEALTHCARE, LLC | 1467 | 1A5162AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |