BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2912059 · Received January 11, 2013

    Report

    Report Number
    1319809-2013-00022
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 11, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, REPRODUCIBLE HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE PREDICTED WHILE USING THE VITROS 5600 SYSTEM. THERE WAS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. EXPECTED PERFORMANCE OF THE VITROS PHBR REAGENT WAS RETURNED USING AN ALTERNATE LOT OF VITROS TDM PV I CONTROL FLUID. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, VITROS TDM PV I LOT G1647 AND VITROS PHBR REAGENT LOT 2538-0060-7822 COULD NOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, REPRODUCIBLE HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS (QC FLUID LOT G1647 = 15.2, 14.7, 14.8, 14.0 VS. AN EXPECTED RESULT= 10.83 NG/ML) USING A VITROS 5600 SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER TWO OF FOUR MDR'S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16864 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 2538-0060-7822

    Patients

    Seq Age Sex Outcome Treatment
    1