BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 3920269 · Received July 8, 2014

    Report

    Report Number
    1319808-2014-00014
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE VITROS VALP RESULTS WERE OBTAINED ON QUALITY CONTROL FLUIDS PROCESSED ON A VITROS 5, 1FS CHEMISTRY SYSTEM. THE DEFINITIVE ASSIGNABLE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE, A REAGENT OR INSTRUMENT ISSUE CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. IN ADDITION, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, USER ERROR CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS VALP RESULTS ON VITROS QUALITY CONTROL FLUIDS PROCESSED ON A VITROS 5, 1FS CHEMISTRY SYSTEM. VITROS VALP REAGENT, LOT 2511-22-3413. TDM LEV I VITROS VALP= 43.7, 45.5, 38.5, 41.2 VERSUS EXPECTED 27.7 UG/ML. TDM LEV II VITROS VALP= 91.2, 95.6, 86.7, 87.2, 92.4, 82.6, 83.0 VERSUS EXPECTED 62.7 UG/ML. TDM LEV III VITROS VALP = 10 RESULTS > 150 AND 147.7 VERSUS EXPECTED 119.9 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 VITROS VALP PATIENT SAMPLES WERE RUN WITHIN THE TIME FRAME OF THE EVENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO 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
    397292 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-22-3413

    Patients

    Seq Age Sex Outcome Treatment
    1