BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SAMPLE HANDLER PRIME

    MDR report key: 13655389 · Received March 2, 2022

    Report

    Report Number
    2432235-2022-00064
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    February 10, 2022
    Report Date
    March 2, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002439
    PMA / PMN Number
    K161954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE THE UNITED STATES CUSTOMER CONTACTED SIEMENS TO REPORT THAT A SAMPLE ID BARCODE MISREAD OCCURRED FOR ONE PATIENT SAMPLE WHEN USING AN ATELLICA SAMPLE HANDLER PRIME (SHP) ANALYZER HANDHELD BARCODE READER. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INSPECT THE ANALYZER. THE CSE FOUND THAT THE CUSTOMER PRINTED A NEW BARCODE LABEL TO USE FOR THE MANUAL DILUTION AND THE ANALYZER INTERPRETED THE SAMPLE ID INCORRECTLY. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE SAMPLE TUBE THAT HAD THE MISREAD. THE CSE USED THE CUSTOMER'S PRINTER TO GENERATE A NEW LABEL WITH SAMPLE ID (B)(4), THEN USED THE HANDHELD BARCODE READER TO SCAN THE LABEL. THE LABEL READ CORRECTLY TEN TIMES INDICATING THE HANDHELD BARCODE READER WAS OPERATING CORRECTLY. THE CAUSE OF THE SAMPLE ID MISREAD IS UNKNOWN. THE ANALYZER IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS ANALYZER IS NEEDED.

    Description of Event or Problem · 0

    A SAMPLE ID BARCODE MISREAD OCCURRED FOR ONE PATIENT SAMPLE WHEN USING AN ATELLICA SAMPLE HANDLER PRIME (SHP) ANALYZER HANDHELD BARCODE READER. THE SAMPLE WAS TESTED FOR CREATINE KINASE. THE TEST RESULT WAS RELEASED TO THE PHYSICIAN(S) AND LATER RECALLED WHEN THE BARCODE MISREAD WAS REALIZED. 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
    339199 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 29 YR Male