BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH 930 ANALYZER

    MDR report key: 7938298 · Received October 5, 2018

    Report

    Report Number
    2432235-2018-00371
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    July 2, 2018
    Report Date
    October 5, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002163
    PMA / PMN Number
    K151767
    Removal / Correction Number
    2432235-10/05/2018-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS REVIEWED THE INSTRUMENT FILES AND DETERMINED THAT THE INITIAL SERUM INDICES WERE OBTAINED USING THE (HEMOLYSIS [H], ICTERUS [I], AND LIPEMIA [L]) OUTPUT FROM A UREA NITROGEN (UN_C) DONOR METHOD SIGNAL FED THROUGH STANDALONE HIL CALCULATIONS. SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT SERUM INDICES CALCULATED WHEN SAMPLES ARE TESTED FOR ALANINE AMINOTRANSFERASE (ALT), ASPARTATE AMINOTRANSFERASE (AST), LACTATE DEHYDROGENASE L- P (LDLP), AND UN_C ON THE ATELLICA CH 930 ANALYZER MAY NOT BE CONSISTENT WITH THE SAMPLES OR THE INDEPENDENTLY DERIVED H, I, AND L INDICES OBTAINED ON THE INSTRUMENT. THE INVESTIGATION BY SIEMENS DETERMINED THAT THE ISSUE MAY CAUSE INCORRECT FLAGGING OF RESULTS, DEPENDING ON THE DIRECTION AND DEGREE OF INDEX DIFFERENCE AND THE ANALYTE HIL INDEX THRESHOLD. IN THE SCENARIO OF A HIGHER HIL INDEX THAN THE TRUE INDEX, RESULTS MAY BE FLAGGED FOR A HIGH SPECIMEN INDEX WHEN TRULY BELOW THE INDEX THRESHOLD FOR AN ANALYTE, WHICH WOULD BE APPARENT TO THE USER. IN THE SCENARIO OF A SIGNIFICANTLY LOWER HIL INDEX THAN THE TRUE INDEX, RESULTS MAY NOT BE FLAGGED AS APPROPRIATE. THE LIKELIHOOD OF INAPPROPRIATE FLAGGING LEADING TO AN INDEX CHANGE AND A SUBSEQUENT CLINICALLY SIGNIFICANT EFFECT IS REMOTE. SIEMENS IS NOT RECOMMENDING A REVIEW OF PREVIOUSLY GENERATED RESULTS. STARTING ON 26-SEP-2018, AN URGENT MEDICAL DEVICE CORRECTION (UMDC) ASW18-03.A.US WILL BE SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) ASW18-03.A.OUS WILL BE SENT TO OUTSIDE THE US (OUS) CUSTOMERS. THE UDMC AND UFSN ADVISE CUSTOMERS TO NOT ORDER H, I, OR L SERUM INDICES IN THE SAME ORDER WITH ALT, AST, LDLP, OR UN_C TESTS. IN ORDER TO GET CORRECT SERUM INDICES VALUES, SIEMENS INSTRUCTED CUSTOMERS TO ORDER THE SERUM INDICES ON THE SYSTEM OR FROM THE LABORATORY INFORMATION SYSTEM (LIS), IN A SEPARATE ORDER WITHOUT ANY OF THE DONOR METHODS (ALT, AST, LDLP, OR UN_C). ALTERNATIVELY, THE CUSTOMER CAN TURN OFF THE AUTOMATIC HIL ORDERING FROM THE SETTINGS SCREEN: (SETUP->SETTINGS->GENERAL SETUP->PATIENT->HIL ORDERING) BY SELECTING "NEVER AUTOMATICALLY ORDER".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DISCORDANT, FALSELY ELEVATED SERUM INDICES (HEMOLYSIS [H] AND ICTERUS [I]) WERE OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. AN ERROR MESSAGE WAS PRODUCED BY THE INSTRUMENT AT THE TIME THE SAMPLE WAS ANALYZED, BUT THE INDICES WERE SENT TO THE LABORATORY INFORMATION SYSTEM (LIS). THE CUSTOMER NOTICED THAT THE SAMPLE WAS NOT VISIBLY HEMOLYZED AND ORDERED SEPARATE HIL TESTS ON THE SAME INSTRUMENT, RESULTING IN LOWER HEMOLYSIS AND ICTERUS INDICES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE THE DIFFERENT SERUM INDICES OBTAINED ON THE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779099 ATELLICA CH 930 ANALYZER ATELLICA CH 930 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER 00630414002163

    Patients

    Seq Age Sex Outcome Treatment
    1