FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 266992
·
Received March 1, 2000
Report
- Report Number
- 2939301-2000-00134
- Event Type
- Malfunction
- Date Received
- March 1, 2000
- Report Date
- February 3, 2000
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RPTR DID BACK TO BACK BLOOD GLUCOSE TESTS, 1 AFTER THE OTHER, USING DIFFERENT FINGER STICKS AND STRIPS. THE RESULTS WERE 222, 184 AND 17MG/DL. RPTR DID NOT HAVE ANY SYMPTOMS. A CONTROL TEST OF 125 WAS IN RANGE. ON FOLLOWUP, RPTR STATES HAVING ENOUGH BLOOD ON STRIP FOR THE LAST (17MG/DL) TEST, AND THAT THE CONFIRMATION DOT WAS COMPLETELY BLUE. RPTR DID NOT HAVE SUPPLIES FOR FURTHER CONTROL TESTING. 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 |