BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 6499522 · Received April 18, 2017

    Report

    Report Number
    1319809-2017-00040
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 18, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED SODIUM (NA+) RESULT WAS OBTAINED FROM ONE PATIENT SAMPLE PROCESSED USING VITROS NA+ SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE CUSTOMER PROVIDED ACCEPTABLE HISTORICAL VITROS NA+ QUALITY CONTROL RESULTS AND ACCEPTABLE WITHIN RUN VITROS NA+ PRECISION DATA TO RULE OUT VITROS NA+ REAGENT ISSUE AND THE VITROS 350 SYSTEM AS CONTRIBUTORS TO THE EVENT. A LIKELY CAUSE OF THE LOWER THAN EXPECTED VITROS NA+ RESULT IS A PRE-ANALYTICAL SAMPLE HANDLING OR A PRE-ANALYTICAL SAMPLE MIX-UP RELATED ISSUE, ALTHOUGH THIS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A LOWER THAN EXPECTED SODIUM (NA+) RESULT FROM ONE PATIENT SAMPLE (141.6 MMOL/L VERSUS EXPECTED 150.1 MMOL/L) PROCESSED USING VITROS NA+ SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED SODIUM RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283847 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS 4205-0962-6876

    Patients

    Seq Age Sex Outcome Treatment
    1