BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPATHA AUTO INJ SURECLICK

    MDR report key: 8495881 · Received April 8, 2019

    Report

    Report Number
    MW5085646
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 27, 2019
    Manufacturer
    AMGEN INC.
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS INBOUND CALL FROM PT STATED THAT WHEN HE WENT TO INJECT THE REPATHA, THE SURECLICK INJECTOR DID NOT RELEASE THE MEDICATION. HE TRIED MULTIPLE TIMES AND IT DID NOT RELEASE. PT STATED HE THEN TAPPED ON THE PEN AND IT SPILLED ON THE TABLE; UNABLE TO REACH PT, QUITE POSSIBLE PT MISSED ONE DOSE AND NOT SURE IF PT STILL IN POSSESSION OF DEFECTIVE PEN. REPORTED (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283480 REPATHA AUTO INJ SURECLICK INJECTOR PEN NSC AMGEN INC. 1097865A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR