FDA Adverse Event
Malfunction
Summary report: N
PRECISION LINK
MDR report key: 1023537
·
Received March 31, 2008
Report
- Report Number
- 2954323-2008-01252
- Event Type
- Malfunction
- Date Received
- March 31, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 31, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- 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 INFORMED THROUGH ADC FA21DEC2006 LETTER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HIS PRECISION XTRA METER HAD SPONTANEOUSLY CHANGED THE DATE AND TIME. HE ALSO REPORTS USING PRECISION LINK SOFTWARE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION LINK | DATA MANAGEMENT SYSTEM | NBW | ABBOTT DIABETES CARE INC, USA | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |