BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTCHECK ACT+ ABNORMAL

    MDR report key: 6996101 · Received November 2, 2017

    Report

    Report Number
    2250033-2017-00006
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 2, 2017
    Manufacturer
    ACCRIVA DIAGNOSTICS
    Product Code
    GGN
    UDI-DI
    10711234107058
    PMA / PMN Number
    K120977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THIS COMPLAINT IS NOT RELATED TO PRODUCT PERFORMANCE AND THE DEVICE WILL NOT BE EVALUATED, THIS SUBMISSION IS CONSIDERED A FINAL REPORT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED AN INJURY DURING RECONSTITUTION OF A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPED VIAL CONTAINING DILUENT. THE END-USER WAS NOT WEARING GLOVES AND DID NOT USE THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT. THE PURPOSE OF THE SLEEVE IS TO SAFEGUARD END USERS AGAINST POTENTIAL INJURY DURING RECONSTITUTION OF THE CONTROL. WHEN CRUSHING THE VIAL, A GLASS SHARD PROTRUDED THROUGH THE DROPPER VIAL AND PUNCTURED THE USER'S RIGHT THUMB. THE END USER IMMEDIATELY WASHED THE AREA WITH SOAP AND WATER AND COVERED THE CUT WITH A BAND AID. NO FURTHER MEDICAL ATTENTION WAS SOUGHT. NO SIGNIFICANT BLOOD LOSS OR MEDICAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777663 DIRECTCHECK ACT+ ABNORMAL PLASMA, COAGULATION CONTROL GGN ACCRIVA DIAGNOSTICS DCJACT-A C7DCA008 10711234107058

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR