FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 239429
·
Received September 7, 1999
Report
- Report Number
- 2939301-1999-00713
- Event Type
- Malfunction
- Date Received
- September 7, 1999
- Report Date
- August 8, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 STATED THAT SHE DID BACK TO BACK BLOOD GLUCOSE TESTS, WITHIN MINS OF EACH OTHER, USING SEPARATE FINGER STICKS AND STRIPS. HER RESULTS WERE 240, 139, 212 AND 140 MG/DL. SHE DID NOT HAVE ANY SYMPTOMS. TWO CONTROL TESTS WERE DONE DURING TROUBLESHOOTING, WITH RESULTS IN RANGE, 118 AND 119 (90-135). SHE STATED THAT SHE HAD ADDED A SECOND DROP OF BLOOD TO SOME TESTS (UNSPECIFIED) FOR COVERAGE, TO MAKE THE CONFIRMATION DOT A SOLID BLUE. THE LIFESCAN REP REVIEWED CLEANING, TESTING TECHNIQUE, DEEPER PENETRATION CAP USAGE, AND FINE TIP LANCETS 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 | 46 YR | Other |