BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SOLUTION

    MDR report key: 9340511 · Received November 19, 2019

    Report

    Report Number
    2432235-2019-00419
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    September 3, 2019
    Report Date
    May 19, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414007960
    PMA / PMN Number
    K151792
    Removal / Correction Number
    2432235-05/15/2020-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 2432235-2019-00419 WAS FILED ON 19-NOV-2019. SIEMENS INVESTIGATED THE ISSUE AND FOUND THAT THE OBSERVED BEHAVIOR WILL OCCUR IF THE SAMPLE CONTAINER (TTSC) DOES NOT CONTAIN THE MINIMUM REQUIRED VOLUME (MRV) OF SAMPLE FOR TESTING. THE ATELLICA SOLUTIONS OPERATOR'S GUIDE, SECTION 9 SAMPLE MANAGEMENT, PROVIDES A DESCRIPTION OF THE MRV AND THE UNUSABLE SAMPLE VOLUME THAT IS REQUIRED FOR TESTING. THE CAUSE OF NOT DETECTING INSUFFICIENT SAMPLE AND NOT FLAGGING SAMPLES THAT ARE INSUFFICIENT WITH SAMPLE INTEGRITY ERRORS WAS A FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS NEEDED. SECTION H6 EVENT PROBLEM AND EVALUATION CODES WAS UPDATED.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2019-00419 ON 19-NOV-2019 A SUPPLEMENTAL MDR 2432235-2019-00419_S1 WAS FILED ON 19-MAR-2020 FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION (02-MAY-2020): SIEMENS HAS DETERMINED THAT THERE IS A POTENTIAL TO GENERATE RESULTS ON SAMPLES WITH INSUFFICIENT VOLUME USING THE ATELLICA IM 1300 AND IM 1600 ANALYZERS. THIS CAN HAPPEN WHEN SAMPLES ARE PROCESSED IN SPECIFIC SAMPLE TUBES LISTED IN THE URGENT MEDICAL DEVICE CORRECTION (UMDC). THE MINIMUM REQUIRED VOLUME (MRV) DEFINED IN THE ATELLICA OPERATOR GUIDE, SMN 11069101, SECTION 9 SAMPLE MANAGEMENT MUST BE USED WHEN SAMPLE CONTAINERS ARE IN USE. HOWEVER, IF THE VOLUME OF SAMPLE IN THE CONTAINER DOES NOT MEET THE MRV, THE SHAPE OF THE TUBE BOTTOM IN CONJUNCTION WITH THE SAMPLE PROBE MOVEMENT MAY GIVE A FALSE TOTAL SAMPLE VOLUME THAT FAILS TO TRIGGER AN "INSUFFICIENT SAMPLE" FLAG. THIS FAILURE TO TRIGGER AN "INSUFFICIENT SAMPLE" FLAG DOES NOT OCCUR FOR EVERY TRUE CASE OF INSUFFICIENT SAMPLE VOLUME. ANY SAMPLE TYPE (QUALITY CONTROL, CALIBRATORS AND PATIENT SAMPLES) MAY BE AFFECTED AND ERRONEOUSLY DEPRESSED RESULTS MAY BE GENERATED. THE MAGNITUDE OF THE IMPACT DEPENDS ON THE AMOUNT OF SAMPLE THAT FAILED TO ASPIRATE, WITH AN INCREASED EFFECT AS THE SAMPLE VOLUME ASPIRATED IS REDUCED. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) ASI20-02.A.US WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) ASI20-02.A.OUS WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS IN MAY OF 2020. THE UMDC AND UFSN EXPLAIN THE BEHAVIOR DESCRIBED ABOVE AND CUSTOMERS ARE DIRECTED TO FOLLOW THE INSTRUCTIONS FOR USE ON ALL CONTAINERS AND ENSURE THAT THE MINIMUM REQUIRED SAMPLE VOLUME IS PUT INTO ALL SAMPLE CONTAINER TYPES USED ON THE ATELLICA IM 1300 AND 1600 ANALYZERS. TO DATE, THERE ARE NO ALLEGATIONS OF INJURY DUE TO THIS BEHAVIOR.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED FROM THE CUSTOMER SITE BY SIEMENS PERSONNEL THAT THE ATELLICA IM 1300 INSTRUMENT IS NOT DETECTING INSUFFICIENT SAMPLE AND FLAGGING SAMPLES THAT ARE INSUFFICIENT WITH SAMPLE INTEGRITY ERRORS. SIEMENS PERSONNEL PERFORMED AN EXPERIMENT AT THE CUSTOMER SITE USING A TUBE TOP SAMPLE CUP (TTSC) AND ORDERED TWO TROPONIN (TNIH) TESTS (REPLICATES) FROM THAT CUP. THE FIRST ASPIRATION GAVE A HIGHER RESULT THAN THE SECOND ASPIRATION. THE INSTRUMENT DID NOT DETECT INSUFFICIENT SAMPLE AND DID NOT FLAG THE SECOND RESULT WITH A SAMPLE INTEGRITY ERROR. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATELLICA IM 1300 INSTRUMENT IS NOT DETECTING INSUFFICIENT SAMPLE AND FLAGGING SAMPLES THAT ARE INSUFFICIENT WITH SAMPLE INTEGRITY ERRORS. IT IS UNKNOWN IF THERE WERE DISCORDANT PATIENT TEST RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134832 ATELLICA SOLUTION ATELLICA IM 1300 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 00630414007960

    Patients

    Seq Age Sex Outcome Treatment
    1