FDA Adverse Event
Malfunction
Summary report: N
ASCENSIA BREEZE2 TEST STRIPS (50)
MDR report key: 1053387
·
Received May 22, 2008
Report
- Report Number
- 1826988-2008-00535
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 23, 2008
- Report Date
- April 23, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER CALLED BECAUSE HE HAD RECEIVED A HIGH GLUCOSE READING OF 534 MG/DL. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 161 MG/DL. THE NORMAL CONTROL RANGE WAS 88-120 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT TEST STIRPS WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSIA BREEZE2 TEST STRIPS (50) | BLOOD GLUCOSE TEST STRIPS | NBW | BAYER HEALTHCARE, LLC | NOT PROVIDED | 1A5160AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |