BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    MDR report key: 17759783 · Received September 15, 2023

    Report

    Report Number
    0001319809-2023-00108
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    June 8, 2022
    Report Date
    September 15, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JID
    UDI-DI
    10758750009602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. THE ASSIGNABLE CAUSE OF THE EVENT WAS NOT ABLE TO BE DETERMINED. AS NO QUALITY CONTROL RESULTS WERE AVAILABLE FOR REVIEW, A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENTS. AS NO PRECISION TESTING WAS PERFORMED ON THE VITROS 5600 SYSTEMS AROUND THE TIME OF THE EVENTS, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENTS. THE CUSTOMER¿S PROTOCOL FOR PREPARING AND HANDLING THE CAP SAMPLE FLUIDS IS UNKNOWN AND A SAMPLE RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENTS. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS AMON.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED FROM CAP PROFICIENCY FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. FOR (B)(6)2022 ON J1: CHM-06 RESULT OF 437 UMOL/L VS AN EXPECTED RESULT OF 312.9 UMOL/L CHM-07 RESULT OF 290 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L CHM-08 RESULT OF 299 UMOL/L VS AN EXPECTED RESULT OF 219.6 UMOL/L CHM-09 RESULT OF 464 UMOL/L VS AN EXPECTED RESULT OF 334.1 UMOL/L CHM-10 RESULT OF 284 UMOL/L VS AN EXPECTED RESULT OF 215.9 UMOL/L FOR 28 OCTOBER 2022 ON J1: CHM-11 RESULT OF 394 UMOL/L VS AN EXPECTED RESULT OF 309.7 UMOL/L CHM-12 RESULT OF 577 UMOL/L VS AN EXPECTED RESULT OF 452.2 UMOL/L CHM-13 RESULT OF 446 UMOL/L VS AN EXPECTED RESULT OF 345.2 UMOL/L CHM-14 RESULT OF 188 UMOL/L VS AN EXPECTED RESULT OF 156.0 UMOL/L CHM-15 RESULT OF 424 UMOL/L VS AN EXPECTED RESULT OF 339.3 UMOL/L FOR 19 APRIL 2023 ON J2: CHM-02 RESULT OF 443 UMOL/L VS AN EXPECTED RESULT OF 368.0 UMOL/L CHM-04 RESULT OF 375 UMOL/L VS AN EXPECTED RESULT OF 312.5 UMOL/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 HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN PROCESSING PROFICIENCY FLUIDS. THE CUSTOMER DID NOT STATE WHETHER ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THESE EVENTS. THIS REPORT IS NUMBER FOUR OF TWELVE MDR¿S FOR THIS EVENT. TWELVE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWELVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296005 VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTICS JID ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750009602

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown