FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 274577
·
Received April 19, 2000
Report
- Report Number
- 2939301-2000-00303
- Event Type
- Malfunction
- Date Received
- April 19, 2000
- Report Date
- March 24, 2000
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE RPTR STATES DOING BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN MINUTES. RPTR'S RESULTS WERE 113, 126 AND 173 MG/DL. RPTR DID NOT HAVE ANY SYMPTOMS. THE RPTR IS RECOVERING FROM OPEN HEART SURGERY. RPTR DID NOT KNOW WHEN THE TEST STRIPS WERE OPENED, BUT IT WAS PRIOR TO BEING HOSPITALIZED FOR TWO MONTHS. RPTR DOES NOT HAVE CONTROL SOLUTION FOR 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 | 69 YR | Other |