BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 8126090 · Received December 3, 2018

    Report

    Report Number
    1319809-2018-00145
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    October 1, 2018
    Report Date
    December 3, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT LOWER THAN EXPECTED VITROS CHEMISTRY PRODUCTS SODIUM (NA+) RESULTS WERE ATTAINED FROM COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLES USING VITROS NA+ SLIDES IN COMBINATION WITH A VITROS 350 CHEMISTRY SYSTEM. THE INVESTIGATION COULD NOT DETERMINE AN ASSIGNABLE CAUSE OF THE EVENT. A REAGENT ISSUE AND/OR A CALIBRATION ISSUE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS AS QUALITY CONTROL RESULTS FROM THE TIME OF THE EVENT WERE NOT MEETING EXPECTATIONS. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ SLIDES LOT: 4220-0994-1710. THE ISSUE WAS LATER RESOLVED WHEN AN ALTERNATE REAGENT LOT WAS CALIBRATED AND PUT INTO USE, AND THE SAMPLES WERE TESTED AGAIN. IT IS UNKNOWN IF THE INSTRUMENT WAS PERFORMING AS EXPECTED AT THE TIME OF THE EVENT AS PERFORMANCE TESTING WAS NOT CONDUCTED DURING THAT TIME. THEREFORE, THE INSTRUMENT CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LOWER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLE USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. COLLEGE OF AMERICAN PATHOLOGISTS C-C 2018 SAMPLE CHM-13: NA+ RESULT OF 144 MMOL/L VERSUS AN EXPECTED RESULT OF 150.3 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 LOWER THAN EXPECTED VITROS NA+ RESULT WAS OBTAINED WHEN PROCESSING CAP FLUIDS WITH NO PATIENT RESULTS BEING REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966512 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS 4220-0994-1710

    Patients

    Seq Age Sex Outcome Treatment
    1