BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2930260 · Received January 25, 2013

    Report

    Report Number
    1319809-2013-00036
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 25, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED PROCESSED ON VITROS 5,1 FS CHEMISTRY SYSTEM. THERE WAS NO INDICATION THAT AN ANALYZER RELATED ISSUE CONTRIBUTED TO THE EVENT. A REAGENT RELATED ISSUE OR AN INTERACTION BETWEEN THE VITROS PHBR SLIDES AND THE VITROS 5,1 FS CHEMISTRY SYSTEM, COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. ADDITIONAL INVESTIGATION BY OCD REGARDING VITROS PHBR PERFORMANCE IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE RESULTS OBTAINED ARE AS FOLLOWS: VITROS PHBR LOT 2539-0062-2286: QC LOT M1914 = 46.45, 32.77, 41.13, 44.63, 44.08, 38.60 VS. AN EXPECTED RESULT= 59.0 NG/ML; VITROS PHBR LOT 2541-0064-0287: QC LOT G1647 = 9.3 VS. AN EXPECTED RESULT= 12.77 NG/ML; QC LOT M1914 = 39.2, 46.6, 36.8, 44.2, 46.8, 45.4, 45.9 VS. AN EXPECTED RESULT= 59.83 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO RECUR UNDETECTED WITH PATIENT SAMPLES. NO PATIENT SAMPLES WERE KNOWN TO HAVE BEEN AFFECTED. THERE WAS NO ALLEGATION OF HARM TO PATIENTS AS A RESULT OF THIS EVENT. THIS REPORT IS THREE OF FOURTEEN MDR'S FOR THIS EVENT. FOURTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOURTEEN DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35848 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTICS DLZ ORTHO-CLINICAL DIAGNOSTICS 2539-0062-2286

    Patients

    Seq Age Sex Outcome Treatment
    1