BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH 930 MODULE

    MDR report key: 8875628 · Received August 8, 2019

    Report

    Report Number
    2432235-2019-00260
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    April 4, 2019
    Report Date
    August 8, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002163
    PMA / PMN Number
    K151767
    Removal / Correction Number
    2432235-08/06/2019-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS, INC. HAS CONFIRMED THAT THE ATELLICA CH 930 MODULE MAY REPORT INCORRECT SERUM INDICES FOR HEMOLYSIS (H) AND LIPEMIA (L) WHEN USING THE UN_C TEST AS A DONOR METHOD, AND THE HEMOLYSIS ICTERUS LIPEMIA (HIL) FUNCTION IS ENABLED. DUE TO BUBBLES IN THE REACTION CUVETTE, THERE IS A POTENTIAL FOR FALSELY DEPRESSED 'H' RESULTS (E.G. H INDEX OF 3 OR HIGHER, REPORTED AS LESS THAN OR EQUAL TO 1 ) AT A RATE OF 0.3-1% AND FALSELY ELEVATED 'L' RESULTS (E.G. L INDEX OF 0 REPORTED AS MORE THAN OR EQUAL TO 1) AT A RATE OF 2.9%. IN ALL CASES OF FALSELY DEPRESSED H, L IS ELEVATED MORE THAN OR EQUAL TO1. FOR SAMPLES NOT USING UN_C AS THE DONOR METHOD THE INDICES ARE NOT IMPACTED. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) ASI19-02.A.US WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) ASI19-02.A.OUS WAS SENT TO OUS CUSTOMERS IN JULY 2019. THE UMDC AND UFSN ADVISE CUSTOMERS WHO HAVE MULTIPLE ATELLICA CH 930 ANALYZERS TO GENERATE UN_C RESULTS ON A DIFFERENT ANALYZER THAN THE HIL TESTS. FOR CUSTOMERS WHO HAVE ONLY ONE ATELLICA CH 930 ANALYZER WHEN UN_C IS PART OF THE TEST ORDER AND ALT AND AST ARE NOT, HIL TESTS SHOULD BE ORDERED SEPARATELY, OR ALTERNATIVELY HIL ORDERING CAN BE TURNED OFF.

    Description of Event or Problem · 1

    SEVERAL DISCORDANT, FALSELY ELEVATED LIPEMIA (L) INDICES WERE OBTAINED ON ATELLICA CH 930 MODULE. THE CUSTOMER PROVIDED RESULTS FOR ONLY ONE DISCORDANT, FALSELY ELEVATED LIPEMIA INDEX ON ATELLICA CH 930 MODULE (SAMPLE ID (B)(6)). THE INITIAL INDEX WAS FLAGGED INCORRECTLY, AND IT IS UNKNOWN IF IT WAS REPORTED TO THE PHYSICIAN(S). OBSERVATION FOUND THE SAMPLE TO BE VISUALLY CLEAR WITH NO EVIDENCE OF LIPEMIA. THE REPEAT INDEX FROM THE SAME SAMPLE WAS CORRECT AND IT IS UNKNOWN IF IT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REFERENCED 2 ADDITIONAL SAMPLES, AS AN EXAMPLE, WITH NO RESULTS PROVIDED (SIDS (B)(6)). THE CUSTOMER STATED THAT THIS ONLY HAPPENS WHEN UREA IS USED TO DO THE HIL TESTING AND THAT OTHER ASSAYS DO NOT SHOW THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669135 ATELLICA CH 930 MODULE ATELLICA CH 930 MODULE JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 MODULE 00630414002163

    Patients

    Seq Age Sex Outcome Treatment
    1