BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICH CHECK ONE

    MDR report key: 58780 · Received December 26, 1996

    Report

    Report Number
    2027242-1996-09099
    Event Type
    Injury
    Date Received
    December 26, 1996
    Date of Event
    November 1, 1996
    Report Date
    December 26, 1996
    Manufacturer
    DIAGNOSTIC SOLUTIONS, INC.
    Product Code
    CFR
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED A MEDWATCH REPORT, ACCESS #101285. THE PROBLEM AS STATED ON THE MEDWATCH REPORT FOLLOWS: "PT HAD SERIOUS DIABETES PROBLEMS. STRIP GAVE A READING OF 30 POINTS BELOW PT ACTUAL BLOOD GLUCOSE. PT HAD TO BE HOSPITALIZED. PHARMACIST COMPARED BLOOD GLUCOSE USING CO'S STRIP WITH ANOTHER CO'S STRIP. CO STRIP GAVE INACURATIVE(SIC) BLOOD GLUCOSE READING." THE REPORT WAS FILED BY A REPORTER WHO REQUESTED ANONYMITY. FOR THIS REASON NO ADD'L INFO CAN BE OBTAINED. THE CO REP. HAS CONTACTED THE FDA TO DETERMINE WHETHER THE TEST STRIPS ARE AVAILABLE FOR EVALUATION AS INDICATED IN THE MEDWATCH REPORT AND WILL NOTIFY QA/RA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICH CHECK ONE BLOOD GLUCOSE TEST STRIPS FOR USE WITH ONE TOUCH METERS CFR DIAGNOSTIC SOLUTIONS, INC. 510K: K924398 1K514B

    Patients

    Seq Age Sex Outcome Treatment
    1 *