FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 242101
·
Received September 24, 1999
Report
- Report Number
- 2939301-1999-00777
- Event Type
- Malfunction
- Date Received
- September 24, 1999
- Report Date
- August 26, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METER WAS NOT THE SUBJECT OF FDA RECALL Z-631-8
Description of Event or Problem · 1
THE RPTR STATED THAT SHE DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN 10 MINS, USING SEPARATE FINGERSTICKS. HER RESULTS WERE 108, 165, 101 AND 172 MG/DL. SHE DID NOT HAVE ANY SYMPTOMS. A CONTROL SOLUTION TEST WAS IN RANGE, 131 (100-150). ON FOLLOWUP, THE RPTR STATED THAT WHEN TESTING, IF CONFIRMATION DOT IS NOT COMPLETELY COVERED, SHE PRICKS HER FINGER AGAIN AND PUTS MORE BLOOD ON THE STRIP. THE LIFESCAN REP REVIEWED CLEANING, CODING, USE OF CONTROL SOLUTION AND APPLICATION OF SAMPLE WITH THE RPTR.
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 |