FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 241175
·
Received September 15, 1999
Report
- Report Number
- 2939301-1999-00745
- Event Type
- Malfunction
- Date Received
- September 15, 1999
- Report Date
- August 16, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8
Description of Event or Problem · 1
THE RPTR DID TWO SETS OF BACK TO BACK BLOOD GLUCOSE TESTS. THE FIRST SET OF TESTS RESULTED IN 190, 180 AND 140 MG/DL. THE SECOND SET OF TESTS WERE FROM HIS NON-DIABETIC WIFE AND HER READINGS WERE 110 AND 60 MG/DL. TESTS WERE DONE WITHIN 10 MINS OF EACH OTHER, USING THE SAME FINGERSTICK A COUPLE OF TIMES. THERE WERE NO SYMPTOMS. HE DID NOT HAVE ANY CONTROL SOLUTION FOR TESTING.
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 | 57 YR | Other |