FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 266571
·
Received February 29, 2000
Report
- Report Number
- 2939301-1998-00128
- Event Type
- Malfunction
- Date Received
- February 29, 2000
- Report Date
- September 4, 1998
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RPTR RECEIVED AN ER1 MESSAGE MULTIPLE TIMES WITH BLOOD TESTS. RPTR BELIEVED THE ER1 MESSAGE WAS CAUSED BY DAMAGED TEST STRIPS. RPTR DISPOSED OF THE STRIPS AND PURCHASED A NEW VIAL OF TEST STRIPS. RPTR RECEIVED ER1 MESSAGE WITH THE NEW VIAL OF TEST STRIPS AND CALLED LIFESCAN FOR ASSISTANCE. THE METER MEMORY REPORTED ON THIS CALL WAS ER1, 118, 123, 225, 232, ER4, 279, 109, 332, 221. RPTR ROUTINELY COMPARES THE CONFIRMATION DOT TO THE TEST STRIP COLOR CHART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESTEP | BLOOD GLUCOSE METER | CGA | LIFESCAN, INC. | * | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other | (DATE NA) NA |