BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SOLUTION

    MDR report key: 10796175 · Received November 5, 2020

    Report

    Report Number
    2432235-2020-00434
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    July 28, 2020
    Report Date
    November 5, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    K151792
    Removal / Correction Number
    2432235-11/04/2020-012-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT THE OPERATOR OF AN ATELLICA IM 1600 INSTRUMENT SCANNED THE TEST DEFINITION (TDEF) FOR THE TOTAL HUMAN GONADOTROPIN HORMONE (THCG) TEST. AFTER SCANNING, THE OPERATOR OBSERVED THAT THE SERUM INDICES PARAMETERS OF HEMOLYSIS, ICTERUS AND LIPEMIA (HIL) WERE NOT BEING GENERATED ALONG WITH THE THCG PATIENT SAMPLE TEST RESULTS. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INSPECT THE INSTRUMENT. THE CSE MOVED ALL PATIENT SAMPLE TEST RESULTS TO THE HISTORICAL DATA AND THEN RE-ENABLED THE HIL PARAMETERS RESOLVING THE BEHAVIOR. THE CAUSE OF THE HIL PARAMETERS NOT RUNNING ALONG WITH THE THCG TESTS WAS THE THCG TDEF. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THIS INSTRUMENT IS NEEDED. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) (B)(4) .A.US WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) (B)(4) .A.OUS WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS IN (B)(6) OF 2020. THE UMDC AND UFSN EXPLAIN THE BEHAVIOR DESCRIBED ABOVE AND REQUESTS CUSTOMERS TO ENSURE THAT AFTER SCANNING A NEW VERSION OF THE 2D MASTER CURVE AND TEST DEFINITION BARCODES INCLUDED IN THE REAGENT PACKAGE, THE SETTINGS OF THE CUSTOMIZED FIELDS MUST BE VERIFIED, IF APPLICABLE, ON THE "SETUP/TEST DEFINITION/IM TEST DEFINITION SCREEN" AND IF NECESSARY, CUSTOMIZED SETTINGS MUST BE RE-ENTERED. THE UMDC AND UFSN DELINEATE THAT SOFTWARE IS BEING DEVELOPED TO RESOLVE THE BEHAVIOR. TO DATE, THERE ARE NO ALLEGATIONS OF INJURY DUE TO THIS BEHAVIOR.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ATELLICA IM 1600 INSTRUMENT SCANNED THE TEST DEFINITION (TDEF) FOR THE TOTAL HUMAN GONADOTROPIN HORMONE (THCG) TEST. AFTER SCANNING, THE OPERATOR OBSERVED THAT THE SERUM INDICES PARAMETERS OF HEMOLYSIS, ICTERUS AND LIPEMIA (HIL) WERE NOT BEING GENERATED ALONG WITH THE THCG PATIENT SAMPLE TEST RESULTS. THE OPERATOR NOTICED THE HIL PARAMETERS WERE MISSING ON THE PATIENT SAMPLES AND DID NOT RELEASE THE THCG TEST RESULTS TO THE PHYSICIAN(S). IT IS UNKNOWN HOW MANY SAMPLES WERE TESTED FOR THCG. IT IS UNKNOWN IF THE SAMPLES WERE REPEATED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254743 ATELLICA SOLUTION ATELLICA IM 1600 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1600, 00630414002439

    Patients

    Seq Age Sex Outcome Treatment
    1