FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 221726
·
Received April 30, 1999
Report
- Report Number
- 2939301-1999-00288
- Event Type
- Malfunction
- Date Received
- April 30, 1999
- Report Date
- April 8, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8
Description of Event or Problem · 1
THE REPORTER DID A BACK TO BACK BLOOD GLUCOSE TEST, WITHIN TEN MINUTES, AND GOT RESULTS OF 220, 194, AND 150 MG/DL. REPORTER USED ONE FINGERSTICK. NO SYMPTOMS WERE REPORTED.
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 | 51 YR | Other |