FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 275855
·
Received April 26, 2000
Report
- Report Number
- 2939301-2000-00323
- Event Type
- Malfunction
- Date Received
- April 26, 2000
- Report Date
- March 29, 2000
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE RPTR STATED THAT RPTR DID BACK TO BACK BLOOD GLUCOSE TESTING, WITHIN MINUTES. RPTR'S RESULTS WERE 169, 133, 200 AND 209 MG/DL. RPTR DID NOT HAVE ANY SYMPTOMS. ON FOLLOW UP, THE RPTR STATED THAT RPTR IS ON COUMADIN, AND DOES NOT RECALL IF RPTR USED SEPARATE FINGER STICKS. RPTR HAS BEEN PUTTING MULTIPLE DROPS ONTO STRIP. 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 |