FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 266537
·
Received February 25, 2000
Report
- Report Number
- 2939301-2000-00120
- Event Type
- Malfunction
- Date Received
- February 25, 2000
- Report Date
- January 30, 2000
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RPTR STATED THAT RPTR DID BACK TO BACK BLOOD GLUCOSE TESTS, 15 MINS APART. RPTR'S RESULTS WERE 156 AND 192 MG/DL. RPTR DID NOT HAVE ANY SYMPTOMS. A CONTROL SOLUTION TEST WAS IN RANGE, 134 (102-156). THE RPTR STATED THAT RPTR IS NEWLY DIAGNOSED, AND IS CONTROLLING RPTR'S BLOOD SUGAR WITH DIET. RPTR'S RESULTS HAVE SINCE LEVELED OFF, AND RPTR'S READINGS HAVE BEEN 120-130 MG/DL. 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 | UNKNOWN | Other |