BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS LAC SLIDES

    MDR report key: 6933696 · Received October 10, 2017

    Report

    Report Number
    1319809-2017-00178
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 12, 2017
    Report Date
    October 10, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS LAC RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TWO DIFFERENT SAMPLE COLLECTION DEVICES WERE USED FOR A SINGLE PATIENT SAMPLE WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THIS EVENT IS USER ERROR, AS THE CUSTOMER WAS USING A SAMPLE COLLECTION DEVICE THAT IS NOT RECOMMENDED IN THE VITROS LAC INSTRUCTIONS FOR USE. THERE WAS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE VITROS LAC REAGENT LOT IN USE (LOT 3531-0094-5661) OR OF THE VITROS 5600 INTEGRATED SYSTEM.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A DISCORDANT VITROS LACTATE (LAC) RESULT ON A VITROS 5600 INTEGRATED SYSTEM WHEN TWO DIFFERENT COLLECTION DEVICES WERE USED FOR PATIENT SAMPLE TESTING. PATIENT 2 SAMPLE VITROS LAC RESULT 4.5 MMOL/L VERSUS EXPECTED 2.7 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO OCCUR UNDETECTED. THE DISCORDANT VITROS LAC RESULT WAS NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718963 VITROS CHEMISTRY PRODUCTS LAC SLIDES IN-VITRO DIAGNOSTIC KHP ORTHO-CLINICAL DIAGNOSTICS 3531-0094-5661

    Patients

    Seq Age Sex Outcome Treatment
    1