FDA Adverse Event
Malfunction
Summary report: N
SOFT TACT/SOF-SENSE BLOOD GLUCOSE METER
MDR report key: 382421
·
Received February 28, 2002
Report
- Report Number
- 1220459-2002-00016
- Event Type
- Malfunction
- Date Received
- February 28, 2002
- Date of Event
- February 19, 2002
- Report Date
- February 28, 2002
- Manufacturer
- MEDISENSE, INC
- Product Code
- LFR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A COMPLAINT WAS REC'D THAT A HOSPITAL FACILITY REC'D A LOW BLOOD GLUCOSE READING OF 140 MG/DL ON A SOFTTACT/SOF-SENSE METER WHEN COMPARED TO A VALID LABORATORY READING OF 150 MG/DL. THESE VALUES, WHEN PLOTTED ON A CLARKE ERROR GRID, FALL INTO THE "D" ZONE SHOWING THE DIFFERENCE IN RESULTS TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFT TACT/SOF-SENSE BLOOD GLUCOSE METER | BLOOD GLUCOSE METER | LFR | MEDISENSE, INC | NA | 30102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |