FDA Adverse Event
Malfunction
Summary report: N
SURESTEP
MDR report key: 233241
·
Received July 23, 1999
Report
- Report Number
- 2939301-1999-00555
- Event Type
- Malfunction
- Date Received
- July 23, 1999
- Report Date
- June 24, 1999
- Manufacturer
- LIFESCAN, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 TESTING WITH RESULTS OF 287, 260, 152 AND 190 MG/DL. TESTS WERE DONE WITHIN 10 MINS, USING SEPARATE FINGERSTICKS. RPTR SAID THAT SHE HAS SYMPTOMS NOT RELATED TO HIGH OR LOW BLOOD SUGAR, BUT FROM A REACTION TO MEDICATION. A CONTROL SOLUTION TEST OF 125 MG/DL WAS WITHIN RANGE.
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 |