FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE TEST STRIPS 100'S
MDR report key: 1981274
·
Received February 2, 2011
Report
- Report Number
- MW5019290
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 24, 2011
- Report Date
- January 24, 2011
- Manufacturer
- ABBOTT
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
THE PT STATES HE IS GETTING BLOOD SUGAR RESULTS THAT ARE 10-15 UNITS OFF FROM WHAT HE GOT USING THE OLD STRIP, USING ONE AFTER THE OTHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE TEST STRIPS 100'S | TEST STRIP | NBW | ABBOTT | 1034017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |