FDA Adverse Event
Summary report: N
QUICK CHECK ONE
MDR report key: 67723
·
Received February 7, 1997
Report
- Report Number
- 2027242-1997-90040
- Date Received
- February 7, 1997
- Report Date
- January 10, 1997
- Manufacturer
- DIAGNOSTIC SOLUTIONS, INC.
- Product Code
- CFR
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PHARMACY CLERK REPORTED THAT A CUSTOMER HAD RETURNED A BOX OF TEST STRIPS COMPLAINING OF INACCURATELY HIGH READINGS. THE CUSTOMER TOLD THE PHARMACY CLERK THAT HE HAD PERFORMED APPROX SIX BLOOD GLUCOSE TESTS AND THAT EACH TIME HE PERFORMED COMPARISON TESTS WITH ANOTHER TEST STRIPS AND OBTAINED RESULTS OF 123, 120, AND 180 MG/DL RESPECTIVELY. THE CUSTOMER PERFORMED A CONTROL SOLUTION STATED AND OBTAINED A RESULT OF 170 VERSUS A NORMAL CONTROL SOLUTION RANGE OF 106-158 MG/DL. THE CUSTOMER STATEED THAT THE CODE WAS SET CORRECTLY FOR ALL TESTS. HE ALS PERFORMED A CHECK STRIP TEST AND OBTAINED A RESULT THAT WAS WITHIN RANGE (SPECIFIC RESULT UNKNOWN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICK CHECK ONE | BLOOD GLUCOSE TEST STRIPS FOR USE WITH ONE TOUCH METERS | CFR | DIAGNOSTIC SOLUTIONS, INC. | * | 16199A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |