BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 1052415 · Received May 20, 2008

    Report

    Report Number
    1319808-2008-00142
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT THE USER WAS PERFORMING A CROSSOVER TEST WITH AGED SAMPLES. BOTH SAMPLES HAD BEEN STORED FROZEN FOR 1 MONTH AND 2 MONTHS, RESPECTIVELY. THE VITROS VALP INSTRUCTIONS FOR USE RECOMMENDED A MAXIMUM OF 14 DAYS FROZEN STORAGE OF SAMPLES. THE COMPARATIVE METHOD RESULTS WERE BASED ON FRESH ASSAYS OF THE SAMPLES. THE BIASED RESULTS WERE RE-ASSAYED AND THE BIASED RESULTS WERE CONFIRMED. THE CUSTOMER WAS ADVISED OF THE NEED TO ASSAY SAMPLES THAT ARE LESS THAN OR EQUAL TO 14 DAYS OF AGE. THE CUSTOMER PLANS TO REPEAT TESTING WITH FRESH SAMPLES. ALTHOUGH THE DEFINITIVE ROOT CAUSE IS UNKNOWN, SAMPLE HANDLING THAT WAS NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED TWO POSITIVELY BIASED PATIENT RESULTS USING VITROS VALP REAGENT ON A VITROS 5,1 FS CHEMISTRY ANALYZER WHEN COMPARED TO AN ALTERNATE METHOD FOR VALP. THERE WAS NO ALLEGATION OF PATIENT HARM AND RESULTS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DEVICE LEG ORTHO-CLINICAL DIAGNOSTICS NA 1511-12-8098

    Patients

    Seq Age Sex Outcome Treatment
    1