BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 5543559 · Received April 4, 2016

    Report

    Report Number
    1319808-2016-00007
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    February 21, 2016
    Report Date
    April 4, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE DISCORDANT, VITROS VALP QUALITY CONTROL FLUID RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE FOR THIS EVENT. WITHIN RUN MARKER PRECISION WAS WITHIN EXPECTATION, THEREFORE, AN INSTRUMENT ISSUE COULD BE RULED OUT AS A CONTRIBUTING FACTOR. HOWEVER, A VITROS VALP REAGENT ISSUE, IMPROPER REAGENT PACK HANDLING OR IMPROPER REAGENT PACK STORAGE CONDITIONS CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THE ASSIGNABLE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE DISCORDANT VITROS VALP QUALITY CONTROL FLUID RESULTS ON A VITROS 5600 INTEGRATED SYSTEM. REAGENT LOT 2511-22-4730, BIORAD LEVEL 1 RESULT OF 46.7, 42.8, 21.9, 53.8 UG/ML VERSUS AN EXPECTED RESULT OF 32.0 UG/ML. BIORAD LEVEL 2 RESULT OF 54.7, 55.3, 86.5 UG/ML VERSUS AN EXPECTED RESULT OF 69.9 UG/ML. BIORAD LEVEL 3 RESULT OF 140.2 UG/ML VERSUS AN EXPECTED RESULT OF 105.3 UG/ML. REAGENT LOT 2511-22-4942, BIORAD LEVEL 2 RESULT OF 51.8, 52.3 UG/ML VERSUS AN EXPECTED RESULT OF 67.0 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. NO PATIENT SAMPLES WERE AFFECTED DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF FOUR MDR'S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202189 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-22-4730

    Patients

    Seq Age Sex Outcome Treatment
    1