FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 251712
·
Received November 23, 1999
Report
- Report Number
- 2939301-1999-00988
- Event Type
- Malfunction
- Date Received
- November 23, 1999
- Report Date
- October 24, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THAT SHE DID BACK TO BACK BLOOD GLUCOSE TESTS WITHIN 5 MINUTES OF EACH OTHER, USING SEPARATE FINGER STICKS. HER RESULTS WERE 212, 427 AND 325 MG/DL. SHE DID NOT HAVE ANY SYMPTOMS. DURING TROUBLESHOOTING, A CONTROL SOLUTION TEST WAS HIGH OUT OF RANGE, 150 (92-138). RETESTED USING NEW CONTROL AND NEW VIAL OF STRIPS, RESULT WAS WITHIN RANGE, 130 (92-138).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURESTEP | BLOOD GLUCOSE MONITORING KIT/SYSTEM | CGA | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |