BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS LAC SLIDES

    MDR report key: 6077402 · Received November 3, 2016

    Report

    Report Number
    1319809-2016-00092
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 8, 2016
    Report Date
    November 3, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE CUSTOMER OBTAINED HIGHER AND LOWER THAN EXPECTED VITROS LACTATE QUALITY CONTROL (QC) RESULTS USING THE VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS MOST LIKELY THE USE OF SUB-OPTIMAL CALIBRATIONS THAT SUBSEQUENTLY CAUSED THE HIGHER AND LOWER THAN EXPECTED LACTATE QUALITY CONTROL RESULTS. THE CUSTOMER OBTAINED MULTIPLE SUB-OPTIMAL CALIBRATION PARAMETERS WHEN COMPARED TO EXPECTED PARAMETERS USING THE SAME VITROS LACTATE LOT WITH THREE DIFFERENT CALIBRATOR KIT LOTS AND THEREFORE, IT IS NOT LIKELY THAT THE ISSUE WAS RELATED TO THE CALIBRATOR KIT LOTS THEMSELVES. IMPROPER PRE-ANALYTICAL CALIBRATOR FLUID HANDLING IS A LIKELY CONTRIBUTING FACTOR, BUT THIS COULD NOT BE DEFINITIVELY CONFIRMED. A SUCCESSFUL RECALIBRATION USING THE SAME LACTATE LOT WAS OBTAINED WITH NO CHANGES TO THE INSTRUMENT OR THE LACTATE REAGENT. A MALFUNCTION OF THE VITROS 5600 INTEGRATED SYSTEMS OR A VITROS LAC REAGENT LOT ISSUE ARE NOT LIKELY CONTRIBUTORS TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER AND LOWER THAN EXPECTED VITROS LACTATE QUALITY CONTROL RESULTS WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. VITROS L1= 2.57, 2.58 VS. EXPECTED 1.34 MMOL/L. VITROS L2= 7.11, 7.11, 7.11, 7.18 VS. EXPECTED 3.84 MMOL/L. BIORAD L1= 4.84 VS. EXPECTED 5.86 MMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE UNEXPECTED VITROS LACTATE RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED AND WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER SIX OF SEVEN MDR'S FOR THIS EVENT. SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVEN DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728762 VITROS CHEMISTRY PRODUCTS LAC SLIDES IN VITRO DIAGNOSTICS KHP ORTHO-CLINICAL DIAGNOSTICS 3531-0091-1618

    Patients

    Seq Age Sex Outcome Treatment
    1