FDA Adverse Event
Malfunction
Summary report: N
SOFT TACT/SOF-SENSE BLOOD GLUCOSE METER
MDR report key: 386067
·
Received March 27, 2002
Report
- Report Number
- 1220459-2002-00027
- Event Type
- Malfunction
- Date Received
- March 27, 2002
- Report Date
- March 27, 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 RECEIVED THAT A CONSUMER RECEIVED A HIGH BLOOD GLUCOSE READING OF 324 MG/DL ON A SOFTTACT/SOF-SENSE METER WHEN COMPARED TO A VALID LABORATORY READING OF 135 MG/DL. THESE VALUES, WHEN PLOTTED ON A CLARKE ERROR GRID, FALL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN RESULTS TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |