BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STA COMPACT MAX

    MDR report key: 9046001 · Received September 13, 2019

    Report

    Report Number
    8043723-2019-00008
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    August 12, 2019
    Report Date
    June 25, 2025
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    UDI-DI
    03607450589900
    PMA / PMN Number
    K130090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    A LAB TECHNICIAN MANUALLY ENTERED AN INCORRECT RESULT FOR A PATIENT: 20.0 ¿G/ML INSTEAD OF 0.37¿G/ML. THE TECHNICIAN CONFUSED THE END PART OF THE NAME OF THE ASSAY "LIA-TEST DDI 20 ¿G/ML" AS THE RESULT. CUSTOMER ACKNOWLEDGED THERE WAS NOTHING WRONG WITH THE ANALYZER. INSTRUCTIONS WERE GIVEN TO CUSTOMER TO CHANGE THE NAME OF THE TEST, TO AVOID CONFUSION. BASED UPON THE REPORTED RESULT THE PATIENT RECEIVED A CT ANGIOGRAM. THIS DID NOT RESULT IN ANY INJURY, IMPAIRMENT, OR DEATH TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823709 STA COMPACT MAX IVD COAGULATION DEVICE/INSTRUMENT JPA DIAGNOSTICA STAGO S.A.S. 58990 03607450589900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other