FDA Adverse Event
Malfunction
Summary report: N
PRECISION LINK
MDR report key: 2001760
·
Received February 25, 2011
Report
- Report Number
- 2954323-2011-01740
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- January 30, 2011
- Report Date
- February 25, 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. CUSTOMERS AND RETAILERS HAVE BEEN NOTIFIED THROUGH THE ADC FA21DEC2006 LETTER.
Description of Event or Problem · 1
A CUSTOMER REPORTED RECEIVING AN E6 MESSAGE ON THE DISPLAY OF THEIR PRECISION XTRA BLOOD GLUCOSE METER. IT WAS THEN ADDITIONALLY IDENTIFIED BY ADC CUSTOMER SERVICE THAT THE DATE AND TIME SETTINGS IN THEIR METER WERE NOT PROPERLY SET, AND THEY REPORTED TO BE 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 | 45645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |