FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 226254
·
Received June 1, 1999
Report
- Report Number
- 2939301-1999-00347
- Event Type
- Malfunction
- Date Received
- June 1, 1999
- Report Date
- May 2, 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 FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THAT SHE DID A BLOOD GLUCOSE TEST WITH A RESULT OF O MG/DL, AND THAT 30 MINUTES LATER SHE HAD A HEALTHCARE PROFESSIONAL METER TEST DONE WITH A RESULT OF 81 MG/DL. THE REPORTER DID NOT HAVE ANY SYMPTOMS. SHE STATED THAT THE TEST STRIPS SHE USED WERE EXPIRED, AND SHE DID NOT HAVE ANY OTHER SUPPLIES AVAILABLE FOR A CONTROL TEST.
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 | 79 YR | Other |