BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL QUICKVUE ONE STEP

    MDR report key: 297992 · Received September 25, 2000

    Report

    Report Number
    MW1020016
    Event Type
    Malfunction
    Date Received
    September 25, 2000
    Report Date
    September 25, 2000
    Manufacturer
    QUIDEL CORP.
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE HUNDRED FIFTY EIGHT QUIDEL URINE HCG TESTS - PRODUCT NUMBER 0269 - WERE USED FOR SERUM TESTING DURING A PERIOD FROM 6/9/00 AND 8/31/00. THREE HUNDRED FIFTY THREE PTS MAY HAVE BEEN TESTED WITH THIS PRODUCT. THIS PRODUCT'S OUTER CONTAINER IS CLEARLY LABELED "HCG URINE." HOWEVER, ONCE PLACED INTO SVC, THE INNER COMPONENTS ARE NOT CLEARLY LABELED. THE INDIVIDUALLY WRAPPED TESTING CASSETTES ARE LABELED AS "QUICKVUE" AND ARE NOT DESCRIBED AS FOR URINE USE ONLY. A CATALOG NUMBER IS NOT PRINTED. NOTHING INDICATES THAT THIS IS FOR URINE TESTING. THE DESCRIPTION PRINTED ON THE CASSETTE FOR THE HCG URINE IS "HCG". AGAIN, NO INDICATION THAT THIS IS FOR URINE ONLY. LOT NUMBERS DIFFER ON THE OUTSIDE CONTAINER AND ON THE FOIL WRAPPED CASSETTE PACKAGES. LOT NUMBERS ARE NOT PRINTED ON THE TESTING CASSETTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIDEL QUICKVUE ONE STEP HCG-URINE LOT NUMBER 0509100 JHJ QUIDEL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other