FDA Adverse Event
Malfunction
Summary report: N
PRECISION PCX
MDR report key: 1041219
·
Received May 8, 2008
Report
- Report Number
- 2954323-2008-01748
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- April 8, 2008
- Report Date
- May 8, 2008
- Manufacturer
- ABBOTT DIABETES CARE LIMITED UK
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION, AND A FOLLOW-UP WILL BE SUBMITTED ONCE RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
A HEALTH CARE FACILITY REPORTED RECEIVING A HIGH READING OF 73 MG/DL ON THEIR PRECISION PCX BLOOD GLUCOSE MONITOR WHILE TESTING ON A PT. A REFERENCE READING OF 42 MG/DL WAS RECEIVED IN THE HOSPITAL'S LAB WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. 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 PCX | BLOOD GLUCOSE METER | NBW | ABBOTT DIABETES CARE LIMITED UK | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |