BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    MDR report key: 3784273 · Received May 1, 2014

    Report

    Report Number
    1319809-2014-00021
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE VITROS AMON QUALITY CONTROL RESULT WAS OBTAINED ON A VITROS 350 CHEMISTRY SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE. BASED ON INFORMATION AVAILABLE, A REAGENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. IN ADDITION, RESULTS OF PRECISION TESTING DEMONSTRATED THAT THE VITROS INSTRUMENT WAS PERFORMING AS EXPECTED AT THE TIME OF THE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE VITROS AMON QUALITY CONTROL RESULT WHEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. QC LPV II F2093 AMON RESULT= 127 ¿MOL/L VS. EXPECTED RESULT= 168.2 ¿MOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER STATED THAT NO VITROS AMON PATIENT RESULTS FROM THE TIME FRAME OF THE EVENT WERE IN QUESTION. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS HAD NOT BEEN AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO OCCUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263049 VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTIC JID ORTHO-CLINICAL DIAGNOSTICS 1015-0233-9590

    Patients

    Seq Age Sex Outcome Treatment
    1