BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 7296305 · Received February 26, 2018

    Report

    Report Number
    1319809-2018-00019
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    January 31, 2018
    Report Date
    February 26, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A PATIENT SAMPLE WHEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM USING GEN 16 NA+ REAGENT LOT. THE ASSIGNABLE CAUSE OF THIS EVENT COULD NOT BE DETERMINED. A PRE-ANALYTICAL SAMPLE HANDLING ISSUE CANNOT BE RULED OUT AS A POTENTIALLY CONTRIBUTING FACTOR. NO WITHIN-RUN PRECISION TESTING WAS COMPLETED TO ASSESS THE PERFORMANCE OF THE VITROS 350 SYSTEM; THEREFORE, AN INSTRUMENT RELATED ISSUE ALSO CANNOT BE COMPLETELY RULE OUT AS A CONTRIBUTING FACTOR. THE ASSIGNABLE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT FROM A PATIENT SAMPLE WHEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM USING GEN 16 NA+ REAGENT LOT. VITROS NA+ RESULT OF 138.9 MMOL/L VERSUS AN EXPECTED RESULT OF 127.4MMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED NA+ RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WERE NO REPORTED ALLEGATIONS OF ACTUAL 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
    139270 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN-VITRO DIAGNOSTIC JGS ORTHO-CLINICAL DIAGNOSTICS 4216-0981-6279

    Patients

    Seq Age Sex Outcome Treatment
    1