BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTEM DELTA SYSTEM

    MDR report key: 7838638 · Received August 31, 2018

    Report

    Report Number
    3005792925-2018-00005
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 31, 2018
    Manufacturer
    TEM INNOVATIONS GMBH
    Product Code
    JPA
    UDI-DI
    04260160470020
    PMA / PMN Number
    K101533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATA REVIEW DETERMINED THERE WAS NO MALFUNCTION OF THE INSTRUMENT OR BARCODE READER. THE CAUSE OF THE PATIENT NUMBER ENDING CHANGING FROM "Y" TO "Z" WAS THAT THE BARCODE READER WAS SET TO A (B)(4) KEYBOARD LAYOUT. THE BARCODE SCANNER WAS RECONFIGURED TO A (B)(4) KEYBOARD LAYOUT, WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT IMPACT, ALTHOUGH THERE IS POTENTIAL FOR REPORTING THE WRONG RESULTS TO A DIFFERENT PATIENT THEREFORE THIS INCIDENT REPORT WAS SUBMITTED. NO ADDITIONAL REMEDIAL ACTION REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THEIR ROTEM DELTA. THEY SCANNED THE BARCODE OF A PATIENT'S ID NUMBER WHICH HAD A LETTER Y AT THE END (EG. S1234567Y) BUT THE LAST LETTER FOR THE ID NUMBER THAT SHOWED ON THE ROTEM DELTA WAS Z (EG. S1234567Z). THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679397 ROTEM DELTA SYSTEM WHOLE BLOOD HAEMOSTASIS SYSTEM JPA TEM INNOVATIONS GMBH DELTA 04260160470020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other