BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SAMPLE HANDLER PRIME

    MDR report key: 7531435 · Received May 22, 2018

    Report

    Report Number
    2432235-2018-00218
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    March 13, 2018
    Report Date
    July 16, 2018
    Manufacturer
    ATELLICA SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    K161954
    Removal / Correction Number
    2432235-07/13/2018-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 2432235-2018-00218 WAS FILED 21-MAY-2018. ADDITIONAL INFORMATION (29-JUN-2018): SIEMENS INITIATED A FIELD CORRECTIVE ACTION. A CUSTOMER COMMUNICATION WAS RELEASED TO THE AFFECTED CUSTOMERS, TITLED URGENT MEDICAL DEVICE CORRECTION, "MULTIPLE ISSUES IDENTIFIED IN ATELLICA SOLUTION SYSTEM SOFTWARE V 1.13 AND LOWER", ASW18-02.A.US, TO US CUSTOMERS, AND URGENT FIELD SAFETY NOTICE TITLED "MULTIPLE ISSUES IDENTIFIED IN ATELLICA SOLUTION SYSTEM SOFTWARE V 1.13 AND LOWER", ASW18-02.A.OUS, WAS RELEASED TO OUS CUSTOMERS. CORRECTION/REMOVAL REPORTING NUMBER 2432235-07/13/2018-002-C. SUPPLEMENTAL MDR 2432235-2018-00109_S2, FILED 16-JUL-2018, WAS SUBMITTED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    MDR 2432235-2018-00109, FILED 19-MAR-2018, AND SUPPLEMENTAL MDR 2432235-2018-00109_S1, FILED 07-MAY-2018, WERE SUBMITTED FOR THE SAME EVENT. THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THE EVENT. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) REPRESENTATIVE EVALUATED THE AVAILABLE DATA (LOG FILES) AND DETERMINED THE SID MISREAD WAS DUE TO THE DEFAULT CONFIGURATION OF THE TUBE CHARACTERIZATION STATION (TCS, THREE CAMERAS) AND THE CUSTOMER'S INTERLEAVED 2 OF 5 (ITF) BARCODE SYMBOLOGY. THE CAUSES OF THE THREE SID MISREADS WAS THE ITF BARCODE SYMBOLOGY AND THE TUBE CHARACTERIZATION STATION (TCS) NOT BEING CONFIGURED FOR CHECKSUM. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION IS NEEDED. MDR 2432235-2018-00109, FILED 19-MAR-2018, AND SUPPLEMENTAL MDR 2432235-2018-00109_S1, FILED 07-MAY-2018, WERE SUBMITTED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THREE SAMPLE IDENTIFICATION (SID) BARCODES WERE MISREAD ON THE ATELLICA SAMPLE HANDLER PRIME INSTRUMENT. THE MISREAD SIDS DID NOT HAVE WORKER ORDERS THEREFORE NO TESTING OCCURRED. THE SAME SAMPLES WERE REMOVED FROM THE SAMPLE HANDLER AND THEN RE-INTRODUCED TO THE SAMPLE HANDLER AND RE-READ. THE SIDS READ CORRECTLY DURING THE RE-READ. THE SAME SAMPLES WERE ALSO PROCESSED ON AN ALTERNATE INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE SID MISREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374205 ATELLICA SAMPLE HANDLER PRIME ATELLICA SAMPLE HANDLER PRIME JJE ATELLICA SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME 00630414002439

    Patients

    Seq Age Sex Outcome Treatment
    1