BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 3080559 · Received April 26, 2013

    Report

    Report Number
    1319808-2013-00027
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, HIGHER THAN EXPECTED, VITROS VALP QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. USER ERROR DUE TO USE OF INAPPROPRIATE BASELINE MEANS OR INADEQUATE VERIFICATION OF THE IN-USE VALP CALIBRATION CURVE CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS FOR THE MAGNITUDE OF BIAS OBSERVED. IN ADDITION, SWAPPING OR PLACING PREVIOUSLY USED METERING PROBOSCISES BACK ONTO THE INSTRUMENT FOR USE, A VITROS VALP REAGENT ISSUE, AND THE MAS QUALITY CONTROL FLUIDS THEMSELVES CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. EXPECTED VITROS VALP PERFORMANCE WAS OBTAINED FOLLOWING RECALIBRATION OF THE SAME REAGENT LOT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE, HIGHER THAN EXPECTED, VITROS VALP QUALITY CONTROL RESULTS ON A VITROS 5600 INTEGRATED SYSTEM. THE FOLLOWING RESULTS WERE OBTAINED: QC FLUID MAS 1 = 42.7, 44.0 VS. AN EXPECTED RESULT = 32.5 - G/ML; QC FLUID MAS 2 = 94.9, 94.7, 95.6, 94.7, 98.0 VS. AN EXPECTED RESULT = 78.0 -G/ML; BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT SAMPLE RESULTS WERE QUESTIONED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182213 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-21-2571

    Patients

    Seq Age Sex Outcome Treatment
    1