FDA Adverse Event
Malfunction
Summary report: N
PRECISION LINK
MDR report key: 1041224
·
Received May 8, 2008
Report
- Report Number
- 2954323-2008-01755
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- April 10, 2008
- Report Date
- May 8, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC.
- 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.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HIS PRECISION XTRA METER HAD SPONTANEOUSLY CHANGED THE DATE AND TIME. IT WAS THEN ADDITIONALLY IDENTIFIED BY ADC CUSTOMER SERVICE THAT THE DATE AND TIME SETTINGS IN HIS METER WERE NOT PROPERLY SET, AND HE 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 LINK | NBW | ABBOTT DIABETES CARE INC. | NA | 42414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |