FDA Adverse Event
Summary report: N
LIFESCAN SURE STEP PRO TEST STRIPS
MDR report key: 2092083
·
Received May 16, 2011
Report
- Report Number
- 2092083
- Date Received
- May 16, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 16, 2011
- Manufacturer
- LIFESCAN
- Product Code
- NBW
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A NURSE ATTEMPTED TO PERFORM QUALITY TESTING (QC) ON A NEW VIAL OF SURESTEP TEST STRIPS. THE HIGH CONTROL TEST WAS ATTEMPTED FIRST AND THE METER FAILED THE QC TEST. THREE ATTEMPTS WERE MADE AND THE METER FAILED ALL THREE TESTS. A NEW BOTTLE OF TEST STRIPS WAS OBTAINED. USING THE SAME METER AND THE SAME QC HIGH AND LOW CONTROL MATERIAL, THE STRIPS FROM THE NEW VIAL PASSED BOTH THE HIGH AND LOW QC CONTROL TESTS EACH ON THE FIRST ATTEMPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESCAN SURE STEP PRO TEST STRIPS | POINT OF CARE GLUCOSE TEST STRIPS | NBW | LIFESCAN | * | 3112736008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |