FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 221584
·
Received April 27, 1999
Report
- Report Number
- 2939301-1999-00278
- Event Type
- Malfunction
- Date Received
- April 27, 1999
- Report Date
- April 6, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8
Description of Event or Problem · 1
THE RPTR STATED THAT HER HUSBAND PERFORMED A BACK TO BACK (RAPID SUCCESSION) BLOOD GLUCOSE TEST WITHIN TEN MINUTES, USING DIFFERENT FINGERSTICKS, WITH RESULTS OF 200, 230, AND 260 MG/DL. 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 | 87 YR | Other |