BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTY PRODUCTS VALP REAGENT

    MDR report key: 6136368 · Received November 30, 2016

    Report

    Report Number
    1319808-2016-00038
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 4, 2016
    Report Date
    January 31, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED FROM VITROS TDM CONTROLS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE MOST LIKELY CAUSE OF THE LOWER THAN EXPECTED QUALITY CONTROL RESULTS ARE THE VALP REAGENT PACKS IN USE AT THE SITE. SOME VITROS VALP REAGENT PACKS WHICH HAVE BEEN ON THE ANALYZER FOR OVER 24 HOURS RESULT IN A NEGATIVE DRIFT IN QUALITY CONTROL RESULTS, WHILE OTHER VITROS VALP REAGENT PACKS OF THE SAME LOT DO NOT SHOW THIS NEGATIVE DRIFT. THERE WAS NO EVIDENCE THAT THE VITROS 5,1 FS SYSTEM MALFUNCTIONED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS VALP RESULTS FROM VITROS TDM CONTROLS USING VITROS CHEMISTRY PRODUCTS VALP REAGENT ON A VITROS 5,1 FS CHEMISTRY SYSTEM. TDM L1 VITROS VALP RESULTS: 12.0, 13.8, 16.8 UG/ML VERSUS EXPECTED VITROS VALP RESULT 25.6 UG/ML; TDM L2 VITROS VALP RESULTS: 47.9, 49.0, 42.9, 48.8, 48.0, 44.8, 47.9, 37.8, 10.0, 48.3, 48.2, 47.9, 38.0, 46.7, 48.1, 48.47, 48.75 AND 47.9 UG/ML VERSUS EXPECTED VITROS VALP RESULT 61.4 UG/ML; TDM L3 VITROS VALP RESULTS: 84.1, 91.2, 74.5, 18.3, 83.2, 89.7 VERSUS EXPECTED 114.0. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. ALTHOUGH THERE WERE NO REPORTS OF AFFECTED PATIENT SAMPLE RESULTS, IT CANNOT BE CONFIRMED THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED AND WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM. THIS REPORT IS NUMBER TEN OF TWELVE MDR'S FOR THIS EVENT. TWELVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWELVE DEVICES WERE INVOLVED. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS NUMBER TEN OF TWELVE MDR'S FOR THIS EVENT. TWELVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWELVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785780 VITROS CHEMISTY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-22-4942

    Patients

    Seq Age Sex Outcome Treatment
    1