BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 3024031 · Received March 27, 2013

    Report

    Report Number
    1319809-2013-00126
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. EXPECTED VITROS PHYT QUALITY CONTROL RESULTS WERE OBTAINED ON A SUBSEQUENT RUN. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE NON-REPRODUCIBLE LOWER THAN EXPECTED VITROS PHENYTOIN (PHYT) QUALITY CONTROL RESULTS (QC FLUID BIORAD 2= 11.75 VS. 14.8; QC FLUID BIORAD 3= 18.92 VS. 24.4; QC FLUID LOT M1914= 21.15 VS. 27.4 UG/ML) ON A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO VITROS PHYT PATIENTS HAD BEEN RUN DURING THE TIMEFRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR'S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER 1435228 /IVD 280472.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125512 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2610-0135-4173

    Patients

    Seq Age Sex Outcome Treatment
    1