BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 2970102 · Received February 20, 2013

    Report

    Report Number
    1319809-2013-00085
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE PREDICTED WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. THERE IS NO EVIDENCE THAT AN INSTRUMENT RELATED ISSUE CONTRIBUTED TO THE EVENT. THE INVESTIGATION CONCLUDES THAT THE AFFECTED RESULTS WERE ASSOCIATED WITH THE USE OF AN ATYPICAL PHBR CALIBRATION THAT WAS NOT VERIFIED PRIOR TO USE. THE SPECIFIC CAUSE OF THE ATYPICAL CALIBRATION IS UNKNOWN. HOWEVER, A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED UPON RECALIBRATING THE SAME REAGENT LOT. ADDITIONAL INVESTIGATION BY OCD REGARDING VITROS PHBR REAGENT IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS USING A VITROS 5,1 FS CHEMISTRY SYSTEM. QC FLUID LOT N2096 = 17.2, 17.5 VS. EXPECTED RESULT = 13.68 UG/ML; QC FLUID LOT P2097 = 37.7 VS. AN EXPECTED RESULT= 30.91 UG/ML; BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO PATIENT SAMPLES WERE RUN FOR VITROS PHBR DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDR'S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73057 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTIC DLZ ORTHO-CLINICAL DIAGNOSTICS 2538-0060-7827

    Patients

    Seq Age Sex Outcome Treatment
    1