FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 263274
·
Received February 14, 2000
Report
- Report Number
- 2939301-2000-00077
- Event Type
- Malfunction
- Date Received
- February 14, 2000
- Report Date
- January 17, 2000
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE RPTR DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN 10 MINUTES, USING SEPARATE FINGERSTICKS. RPTR'S RESULTS WERE 233, 136 AND 104 MG/DL. RPTR DID NOT HAVE ANY SYMPTOMS. A CONTROL SOLUTION TEST WAS LOW OUT OF RANGE, 70 (90-134). ON FOLLOW-UP, THE RPTR CHECKS THE CONFIRMATION DOT FOR ENOUGH BLOOD. RPTR DID ANOTHER CONTROL TEST, USING NEW STRIPS AND CONTROL SOLUTION, AND TESTS WERE BELOW RANGE. NO HARM WAS ALLEGED.
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 | 52 YR | Other |