FDA Adverse Event
Malfunction
Summary report: N
PRECISION LINK
MDR report key: 2130455
·
Received June 16, 2011
Report
- Report Number
- 2954323-2011-03568
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 26, 2011
- Report Date
- June 16, 2011
- Product Code
- NBW
- Removal / Correction Number
- Z-0709-2007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE IS A KNOWN MALFUNCTION WITH THE PRECISION LINK SOFTWARE THAT CAN LEAD TO INCORRECT TRENDING OF RESULTS. THIS OCCURS WHEN RESULTS, OBTAINED ON A METER WITH INCORRECT DATE AND TIME, ARE UPLOADED TO A COMPUTER WITH PRECISION LINK SOFTWARE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED INCORRECT TIME/DATE ON THE DISPLAY OF THEIR ADC BLOOD GLUCOSE METER. THE CUSTOMER ADDITIONALLY REPORTED BEING A USER OF THE PRECISION LINK DATA MANAGEMENT SYSTEM. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION LINK | DATA MANAGEMENT SYSTEM | NBW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |