FDA Adverse Event
Malfunction
Summary report: N
GLUCOMETER ELITE 4 DATE
MDR report key: 1053384
·
Received May 22, 2008
Report
- Report Number
- 1826988-2008-00538
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 24, 2008
- Report Date
- April 24, 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
Additional Manufacturer Narrative · 1
THE TEST STRIPS INFO PROVIDED BY THE CUSTOMER WAS NOT VALID, SO THE METER INFO WAS PROVIDED INSTEAD.
Description of Event or Problem · 1
THE CUSTOMER CALLED FOR HELP WITH HER ELITE METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 200 MG/DL. THE NORMAL CONTROL RANGE WAS 78-113 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STIRPS 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 | GLUCOMETER ELITE 4 DATE | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE, LLC | 3901B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |