FDA Adverse Event
Malfunction
Summary report: N
PRECISION POINT OF CARE
MDR report key: 1951101
·
Received December 28, 2010
Report
- Report Number
- MW5018836
- Event Type
- Malfunction
- Date Received
- December 28, 2010
- Date of Event
- December 27, 2010
- Report Date
- December 28, 2010
- Manufacturer
- ABBOTT DIABETES CARE, LTD.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CLINIC EMAILED URGENT PRODUCT RECALL OF PRECISION POINT GLUCOSE TEST STRIPS PRODUCED BY (B)(4). (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION POINT OF CARE | BLOOD GLUCOSE TEST STRIPS | NBW | ABBOTT DIABETES CARE, LTD. | 45963 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |