FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 251436
·
Received November 19, 1999
Report
- Report Number
- 2939301-1999-00984
- Event Type
- Malfunction
- Date Received
- November 19, 1999
- Report Date
- October 22, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8
Description of Event or Problem · 1
THE REPORTER STATED THAT SHE DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN 10 MINUTES, USING SEPARATE FINGER STICKS. HER RESULTS WERE 132, 174, AND 164 MG/DL. SHE DID NOT HAVE ANY SYMPTOMS. SHE STATED THAT THE CONFIRMATION DOT ON THE UNUSED STRIP WAS A LIGHT "GREENISH "COLOR. SHE RETESTED USING A NEW VIAL OF STRIPS AND BLOOD SUGAR RESULTS WERE "BETTER". A CONTROL SOLUTION TEST WAS REPORTED IN RANGE, THOUGH NO NUMBERS WERE GIVEN.
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 |