BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUICK VUE HCG COMBO TEST

    MDR report key: 748747 · Received July 22, 2005

    Report

    Report Number
    MW1036128
    Event Type
    Other
    Date Received
    July 22, 2005
    Date of Event
    July 15, 2005
    Report Date
    July 21, 2005
    Manufacturer
    QUIDEL
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A QUICK VUE ONE STEP HCG COMBO TEST KIT WAS USED FOR A PATIENT FROM LOT # 701557. THE TEST RESULT CAME BACK INVALID BECAUSE THE SMALL BOX DID NOT HAVE A LINE SHOWING. THE PT WAS ASKED IF SHE COULD URINATE AGAIN AND SHE WAS ABLE TO. WITH THE 2ND URINE SPECIMEN TWO TESTS WERE RUN WITH THE SAME LOT#701557 AND ONE TEST CAME BACK NEGATIVE AND ONE CAME BACK INVALID. THREE DAYS LATER, THE COMPANY'S TECHNICAL SUPPORT LINE WAS CALLED WHO STATED THE USUAL REASON FOR AN INVALID TEST WAS NOT ENOUGH SPECIMEN; MEDICATION BLOCKING THE FINDINGS: WHEN ASKED WHICH DRUGS SHE STATED SHE HAD HEARD THIS BUT THE COMPANY HAD NOT COMPLETED ANY TESTING, THAT IT WAS A CHEMICAL RULE OF DRUG BLOCKING PROCESS THROUGH THE KIDNEYS. THE NEXT DAY I RAN A TEST ON 3 KITS, LOT #701935 WITH POSITIVE CONTROL SOLUTION LOT# 153408 EX. DEC 3, 2005. THE RESULTS SHOWED 2 POSITIVE AND 1 INVALID TEST, ALL HAD THE 4 DROPS AND READ AT 3 MINUTES WITH A TIMER USED. THE INIDIVIDUAL KIT LATER HAD MORE DROPS APPLIED AND REMIANED INVALID. THE KITS WERE TAKEN OUT OF USE IN JULY 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK VUE HCG COMBO TEST NCG TEST KIT DHA QUIDEL * 701557
    2 QUICK VUE HCG COMBO TEST HCG TEST KIT DHA QUIDEL * 701935

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other