BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    MDR report key: 14318128 · Received May 7, 2022

    Report

    Report Number
    1319809-2022-00025
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 10, 2022
    Report Date
    May 6, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS PROCESSED USING VITROS AMON LOT 1018-0256-9803 ON A VITROS 350 CHEMISTRY SYSTEM. THE INVESTIGATION CONCLUDED THAT THE ASSIGNABLE CAUSE OF THIS EVENT WAS USER ERROR WITH INCORRECT INTERPRETATION OF THE AMON RESULT CODES AND PERFORMING A DILUTION OUTSIDE OF ORTHO¿S RECOMMENDED PROTOCOL. THE ANALYZER REPORTED ¿NO RESULT¿ FOR THE VITROS AMON ASSAY WITH RESULT CODES IR (INVALID READING) AND OR (OUTSIDE RANGE). THE CUSTOMER INCORRECTLY ASSUMED THIS MEANT THE AMON CONCENTRATION WAS GREATER THAN THE MEASURING RANGE. THE CUSTOMER PERFORMED A DILUTION HIGHER THAN THE DILUTION FACTOR RECOMMENDED BY ORTHO. HISTORICAL QUALITY CONTROL RESULTS INDICATE VITROS AMON MICROSLIDE LOT 1018-0256-9803 WAS NOT PERFORMING AS INTENDED ON THE VITROS 350 CHEMISTRY SYSTEM, AS THERE WAS WITHIN-LAB IMPRECISION OBSERVED. ALTHOUGH WITHIN-LAB IMPRECISION WAS OBSERVED ON THIS VITROS 350 CHEMISTRY SYSTEM, THE MAGNITUDE OF BIAS OBSERVED WOULD NOT HAVE CONTRIBUTED TO THE HIGHER THAN EXPECTED VITROS AMON RESULT THAT WAS 10 TIMES HIGHER THAN THE EXPECTED RESULT OBTAINED FROM THE NON-VITROS METHOD. THEREFORE, A VITROS AMON SLIDE LOT ISSUE OR AN ANALYZER ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS AMON MICROSLIDE LOT 1018-0256-9803. (B)(4).

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS PROCESSED USING VITROS AMON LOT 1018-0256-9803 ON A VITROS 350 CHEMISTRY SYSTEM. SAMPLE 1 VITROS AMON RESULT OF 559 UMOL/L VERSUS EXPECTED 56 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE ERRONEOUS AMON PATIENT RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HAM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353567 VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTICS JID ORTHO-CLINICAL DIAGNOSTICS 1018-0256-9803

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown