BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS NA+ SLIDES

    MDR report key: 17730809 · Received September 12, 2023

    Report

    Report Number
    0001319809-2023-00092
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 13, 2023
    Report Date
    September 11, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JGS
    UDI-DI
    10758750004812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4207-1092-4757 ON A VITROS 4600 CHEMISTRY SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS NA+ LOT 4207-1092-4757 PERFORMANCE ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT. AN INSTRUMENT RELATED ISSUE COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT AS DIAGNOSTIC PRECISION TESTING WAS NOT PERFORMED ON THE VITROS 4600 CHEMISTRY SYSTEM. HOWEVER, THE RESULTS OF VITROS NA+ WITHIN RUN PRECISION TESTING PERFORMED ON THE INSTRUMENT WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS IT IS UNKNOWN IF THE SAMPLE COLLECTION DEVICE MANUFACTURER¿S RECOMMENDED CENTRIFUGATION PROTOCOL WAS PROPERLY FOLLOWED. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ LOT 4207-1092-4757.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4207-1092-4757 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT SAMPLE RESULT OF >250 MMOL/L VS AN EXPECTED RESULT OF 128.1 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED PATIENT SAMPLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 603096.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231957 VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN-VITRO DIAGNOSTICS JGS ORTHO-CLINICAL DIAGNOSTICS, INC. 4207-1092-4757 10758750004812

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown