FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 193573
·
Received October 23, 1998
Report
- Report Number
- 2939301-1998-00448
- Event Type
- Malfunction
- Date Received
- October 23, 1998
- Report Date
- September 25, 1998
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE REPORTER HAD REC'D ER1 MESSAGES IN THE PAST. SHE WOULD REPEAT THE TEST AND USUALLY GO A NORMAL READING THE SECOND TIME. THERE WAS NEVER A PROBLEM AND NO ALLEGATION OF HARM.
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 | 84 YR | Other |