FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 275826
·
Received April 26, 2000
Report
- Report Number
- 2939301-2000-00322
- 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE RPTR STATED THAT RPTR DID BACK TO BACK BLOOD GLUCOSE TESTS, WITH DIFFERENCE OF 100-200 MG/DL. RPTR'S SPOUSE ASSISTS THE RPTR (RPTR HAS PARKINSONS AND ALZHEIMERS) WITH RPTR'S TESTING. ON FOLLOW UP, SPOUSE GAVE THE RESULTS OF THE SUBJECT TESTS, DONE WITHIN 1 MINUTE OF EACH OTHER, AS 230, 167 AND 135 MG/DL. RPTR DID NOT HAVE ANY SYMPTOMS. SPOUSE STATED THAT SPOUSE PUT 2-3 DROPS OF BLOOD ONTO THE TEST 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 | 79 YR | Other |