FDA Adverse Event
Malfunction
Summary report: N
PRECISION LINK
MDR report key: 1001638
·
Received February 7, 2008
Report
- Report Number
- 2954323-2008-00760
- Event Type
- Malfunction
- Date Received
- February 7, 2008
- Date of Event
- January 10, 2008
- Report Date
- February 7, 2008
- Manufacturer
- ABBOTT DIABETES CARE LIMITED UK
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
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 ERROR 658 DISPLAYING ON THEIR PRECISION XTRA 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 MGMT SYSTEM. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION LINK | DATA MANAGEMENT SYSTEM | NBW | ABBOTT DIABETES CARE LIMITED UK | NA | 42628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |