FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 251944
·
Received November 24, 1999
Report
- Report Number
- 2939301-1999-00989
- Event Type
- Malfunction
- Date Received
- November 24, 1999
- Report Date
- October 25, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THAT HE DID BACK TO BACK BLOOD GLUCOSE TESTS, ONE AFTER THE OTHER, USING DIFFERENT FINGER STICKS AND STRIPS. THE RESULTS WERE 110, 143 AND 125 MG/DL. HE DID NOT HAVE ANY SYMPTOMS. A CONTROLL TEST WAS DONE, BUT RESULTS WERE NOT GIVEN. ON FOLLOW-UP, THE LIFE-SCAN REPRESENTATIVE REVIEWED QC PROCEDURES, DISCUSSED A1C TESTS , AND METER/LAB TESTING WITH THE REPORTER'S WIFE IN THE REPORTER'S ABSENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESTEP | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CGA | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |