BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM 1300 ANALYZER

    MDR report key: 9107114 · Received September 23, 2019

    Report

    Report Number
    2432235-2019-00332
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    September 3, 2019
    Report Date
    May 20, 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

    SIEMENS FILED THE INITIAL MDR 2432235-2019-00332 ON 23-SEPTEMBER-2019. SIEMENS FILED THE FIRST SUPPLEMENTAL MDR 2432235-2019-00332 ON 20-NOVEMBER-2020. ADDITIONAL INFORMATION (17-MARCH-2020): SIEMENS EVALUATED THE EVENT AND NOTED THAT THE CUSTOMER DID NOT FOLLOW OPERATING INSTRUCTIONS TO ALLOCATE UNUSABLE VOLUME WHEN CONDUCTING THE TESTING. WHEN THE OPERATOR FILLS A SAMPLE CUP, THEY MUST CALCULATE THE MRV (MINIMUM REQUIRED VOLUME) FOR THE NUMBER OF TESTS THEY WISH TO RUN. SECTION H6: RESULT CODE AND CONCLUSIONS CODE HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2019-00332 ON 23-SEPTEMBER-2019. SIEMENS FILED THE FIRST SUPPLEMENTAL MDR 2432235-2019-00332 ON 20-NOVEMBER-2019. SIEMENS FILED THE SECOND SUPPLEMENTAL MDR 2432235-2019-00332 ON 08-APRIL-2020. SIEMENS FILED THE THIRD SUPPLEMENTAL MDR 2432235-2019-00332 ON 07-MAY-2020. ADDITIONAL INFORMATION (15-MAY-2020): SIEMENS UPDATED SECTION H9 AND INCLUDED THE CORRECTION/REMOVAL REPORTING NUMBER 2432235-05/15/2020-007-C.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2019-00332 ON 23-SEPTEMBER-2019. CORRECTION (18-NOVEMBER-2019): SECTION B5 WAS UPDATED AS THE 'ATELLICA IM 1600 ANALYZER' DEVICE NAME IS INCORRECT. THE CORRECT NAME IS ATELLICA IM 1300 ANALYZER. SIEMENS IS INVESTIGATING THE EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2019-00332 ON 23-SEPTEMBER-2019. SIEMENS FILED THE FIRST SUPPLEMENTAL MDR 2432235-2019-00332 ON 20-NOVEMBER-2019. SIEMENS FILED THE SECOND SUPPLEMENTAL MDR 2432235-2019-00332 ON 08-APRIL-2020. 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 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. CORRECTION: THE FIRST SUPPLEMENTAL MDR 2432235-2019-00332 INCLUDED THE INCORRECT DATE "20-NOVEMBER-2020". THE CORRECT DATE IS 20-NOVEMBER-2019.

    Description of Event or Problem · 0

    THE CUSTOMER INFORMS THAT THE ATELLICA IM 1300 ANALYZER RAN HIGH-SENSITIVITY TROPONIN I (TNIH), ALPHA FETOPROTEIN (AFP), TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) WITH TUBE-TOP SAMPLE CUPS (TTSC) AND INSUFFICIENT SAMPLE SIZE, AND PRODUCED TEST RESULTS. THE CUSTOMER ALLEGES THAT THE ANALYZER DID NOT GENERATE ERROR FLAGS, AND THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE TNIH, AFP, AND THCG RESULTS THAT WERE PRODUCED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND INFORMED THAT THEIR DISTRIBUTION PIPETTE IS CERTIFIED. THE CUSTOMER INFORMS THAT THE INSTRUMENT DID NOT FLAG AN ERROR OR MALFUNCTION, AND THE ISSUE WAS NOTED DURING ASSAY VALIDATION, QUALITY CONTROLS (QC), AND ROUTINE SAMPLE TESTING. THE CUSTOMER STATED THAT THERE WERE NO STAT SAMPLES AND NO BACKUP ANALYZER OR AN ALTERNATE METHOD FOR TESTING. SIEMENS DISPATCHED A CUSTOMER SERVICE ENGINEER (CSE) TO THE CUSTOMER SITE. THE CSE VERIFIED THE HARDWARE AND SOFTWARE ALIGNMENTS, AND NO ISSUES WERE NOTED. SIEMENS IS INVESTIGATING.

    Description of Event or Problem · 1

    THE CUSTOMER INFORMS THAT THE ATELLICA IM 1600 ANALYZER RAN HIGH-SENSITIVITY TROPONIN I (TNIH), ALPHA FETOPROTEIN (AFP), TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) WITH TUBE-TOP SAMPLE CUPS (TTSC) AND INSUFFICIENT SAMPLE SIZE, AND PRODUCED TEST RESULTS. THE CUSTOMER ALLEGES THAT THE ANALYZER DID NOT GENERATE ERROR FLAGS, AND THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE TNIH, AFP, AND THCG RESULTS THAT WERE PRODUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899136 ATELLICA IM 1300 ANALYZER ATELLICA IM 1300 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1300 ANALYZER 00630414007960

    Patients

    Seq Age Sex Outcome Treatment
    1