FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 195317
·
Received October 28, 1998
Report
- Report Number
- 2939301-1998-00497
- Event Type
- Malfunction
- Date Received
- October 28, 1998
- Report Date
- September 28, 1998
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
RPTR EXPERIENCED THE ER1 MESSAGE "TWELVE TIMES IN THE PAST MONTH". RPTR USES CORRECT TECHNIQUE AND USES COLOR COMPARISON CHART WITH THE BLOOD GLUCOSE RESULT OF "BETWEEN 180-350" MG/DL. RPTR STATED HE USUALLY RETESTS. LATEST RETEST WAS A BLOOD GLUCOSE VALUE OF 288 MG/DL. RPTR DOES THEN DOSE HIMSELF BASED ON THE RESULTS OF METER. RPTR STATES HE CAN TELL WHEN HIS BLOOD GLUCOSE IS HIGH, HE FEELS "DIZZY AND TIRED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESTEP | BLOOD GLUCOSE METER | CGA | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |