BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG REAGENT PACK

    MDR report key: 857659 · Received May 31, 2007

    Report

    Report Number
    9680658-2007-00149
    Event Type
    Malfunction
    Date Received
    May 31, 2007
    Date of Event
    April 23, 2007
    Report Date
    May 3, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION SHOWED THAT UPON 1000 FOLD DILUTION AND RETESTING THE SAMPLE, RESULTS OF >500, 000 IU/ML WERE OBTAINED. TESTING OF THE SAMPLE AT AN ALTERNATE SITE DISPLAYED SIMILAR VALUES. THE EVENT IS CONSISTENT WITH A HIGH DOSE HOOK EVENT. THE INSTRUCTIONS FOR USE OTHER LIMITATIONS SECTION STATES THAT "SAMPLES CONTAINING GREATER THAN 300,000 IU/L JCG MAY READ WITHIN THE REPORTABLE RANGE DUE TO A HIGH DOSE HOOK EFFECT."

    Description of Event or Problem · 1

    AN OCD LAB SPECIALIST REPORTED THAT A CUSTOMER OBSERVED NEGATIVELY BIASED TOTAL B-HCG RESULTS ON A PT SAMPLE. THE BIASED RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MIGHT LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG REAGENT PACK IN VITRO DIAGNOSTIC DHA ORTHO-CLINICAL DIAGNOSTICS NA 940

    Patients

    Seq Age Sex Outcome Treatment
    1 YR