FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 234616
·
Received July 30, 1999
Report
- Report Number
- 2939301-1999-00581
- Event Type
- Malfunction
- Date Received
- July 30, 1999
- Report Date
- June 30, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, 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 10 MINUTES, USING DIFFERENT FINGER STICKS. HER RESULTS WERE 151, 118 AND 253. NO SYMPTOMS WERE REPORTED. TWO CONTROL SOLUTION TESTS WERE IN RANGE WHEN PERFORMED DURING TROUBLESHOOTING (NO DETAILS PROVIDED).
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 | 40 YR | Other |