BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2880282 · Received December 19, 2012

    Report

    Report Number
    1319809-2012-00263
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE MOST LIKELY CAUSE OF THE EVENT IS REAGENT RELATED ISSUE. ADDITIONALLY, AN ATYPICAL CALIBRATION OF AN UNKNOWN CAUSE WAS IN USE AT THE TIME OF THE EVENT. EXPECTED PERFORMANCE WAS RETURNED USING AN ALTERNATE REAGENT LOT. INTERNAL INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED IMPRECISE VITROS PHBR QUALITY CONTROL RESULTS RUN ON A VITROS 5,1 FS CHEMISTRY SYSTEM. QC LOT M1914= 78.0, 77.4, >80.0, 75.9, >80.0, 77.5, 78.4, 78.6, >80.0, 75.6, 75.3, 40.2, 47.4, 43.0, 46.9, 47.6, 46.4, 41.2, 79.9, 48.6, 31.9, 45.8 VS. AN EXPECTED RESULT= 62.7 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. HOWEVER, NO VITROS PHBR PATIENT RESULTS WERE REPORTED DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWENTY TWO MDR'S FOR THIS EVENT. TWENTY TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWENTY TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 2538-0060-7596

    Patients

    Seq Age Sex Outcome Treatment
    1