BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SAMPLE HANDLER PRIME

    MDR report key: 17568705 · Received August 17, 2023

    Report

    Report Number
    2432235-2023-00236
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 21, 2023
    Report Date
    October 13, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    K161954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2023-00236 ON 17-AUG-2023. ADDITIONAL INFORMATION (05-OCT-2023): LABORATORY INFORMATION SYSTEM (LIS) LOG FILES WERE NOT AVAILABLE FOR FURTHER EVALUATION. BASED ON THE INFORMATION AVAILABLE, NO ISSUE WITH THE ATELLICA SAMPLE HANDLER PRIME WAS IDENTIFIED. INVESTIGATION FINDINGS CODE OF SECTION H6 WAS UPDATED TO REFLECT THE ADDITIONAL INFORMATION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT A DELAY IN REPORTING RESULTS FOR A SAMPLE, IDENTIFIED AS 36321074, ON THE ATELLICA SAMPLE HANDLER PRIME. AN APPLICATION SPECIALIST REVIEWED THE INSTRUMENT LOGS AND DETERMINED THE INSTRUMENT FLAGGED THE SAMPLE WITH ¿TUBE IS INVALID BECAUSE OF A DISCREPANCY BETWEEN THE ORIGINAL BARCODE SCAN 36321074 AND THE REPEAT BARCODE SCAN 321074¿THIS CAN HAPPEN WHEN TUBES ARE USING LABELS WITH INSECURE SYMBOLOGIES SUCH AS I2O5 WITH NO CHECK DIGIT. CHECK BARCODE LABEL, ENABLE CHECKSUM FEATURE FOR TCS IS CHECK DIGIT FEATURE IS AVAILABLE FROM THE CUSTOMER LABEL. IF FEATURE IS NOT AVAILABLE, BARCODE LENGTH VERIFICATION CAN BE ENFORCED.¿ WHILE THE SAMPLE IDENTIFIER WAS TRULY 36321074, THE ATELLICA READ THE BARCODE AS 321074. IT IS SUSPECTED THAT THE BARCODE QUALITY WAS COMPROMISED. ADDITIONALLY, THE ATELLICA SAMPLE HANDLER ERROR MESSAGE WAS NOT RECEIVED BY THE CONNECTED DATA MANAGEMENT SYSTEM (DMS). A RULE WAS SET IN THE DMS TO CHECK FOR ANY INCOMPLETE STAT SAMPLES THAT ARE IN STORAGE EVERY 40 MINUTES. IF INCOMPLETE STAT SAMPLES ARE FOUND, THE RULE REQUIRES THE INSTRUMENT TO COMPLETE THEM. THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    WHEN A STAT SAMPLE WAS PROCESSED ON AN ATELLICA SAMPLE HANDLER PRIME, THE CUSTOMER PERCEIVED THAT THE SAMPLE WAS ROUTED TO STORAGE AFTER IT WAS PROCESSED BY THE INSTRUMENT, WITHOUT RELEASING RESULTS TO THE LABORATORY INFORMATION SYSTEM (LIS) AS THE SAMPLE WAS PENDING RESULTS FOR SERUM INDICES. THE CUSTOMER INDICATED THAT THERE WAS LESS THAN AN HOUR OF DELAY IN REPORTING RESULTS AND THE SAMPLE WAS REPROCESSED WHEN A PHYSICIAN INQUIRED ABOUT THE SAMPLE. THE CUSTOMER DID NOT SPECIFY WHICH ASSAYS WERE REQUISITIONED FOR THE SAMPLE. THERE WERE NO DISCORDANT RESULTS AND THERE WAS NO IMPACT ON PATIENT CARE. 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
    1708178 ATELLICA SAMPLE HANDLER PRIME ATELLICA SAMPLE HANDLER PRIME JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME 00630414002439

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown