BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE AP 31GX5MM ASCENDIS 4'500ER

    MDR report key: 18543459 · Received January 19, 2024

    Report

    Report Number
    3002806818-2024-00006
    Event Type
    Injury
    Date Received
    January 19, 2024
    Date of Event
    December 19, 2023
    Report Date
    January 19, 2024
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN EAP PATIENT EXPERIENCED A MEDICAL EMERGENCY AND HOSPITALIZATION OVER A WEEKEND. THE PATIENT BEGAN TO EXPERIENCE PROGRESSIVELY WORSENING SYMPTOMS OF HYPOCALCEMIA AND PROCEEDED TO THE EMERGENCY ROOM WHERE SHE WAS ADMINISTERED FORTEO (WHICH SHE HAD PREVIOUSLY BEEN ON VIA INFUSION PUMP). SHE WAS DISCHARGED FEELING BETTER THE FOLLOWING DAY. REVIEW OF MANUFACTURING PROCESSES AND RECORDS SHOW NO DEVIATIONS FOR THE MAIN BATCH 221399. THE ANGLE FROM THE CANNULA IS 100% CONTROLLED BEFORE FITTING OF THE INNER PROTECTIVE CAP. SILICONIZATION OF THE FRONT AND BACK END HAS PERMEABILITY CHECKED 100% THROUGH AIR FLOW MEASUREMENTS OF THE FLOW STREAM. NOTHING WAS DETECTED IN-PROCESS REGARDING BLOCKAGE OR NARROWING OF THE PATH DURING THE ASSEMBLY PROCESS.FLUID WAS ALSO ABLE TO BE ADMINISTERED DURING THE HANDLING TEST. PERFORMED ON RETAINED SAMPLES FROM THE SAME BATCH NO DEVICE PROBLEM CAN BE FOUND.

    Description of Event or Problem · 0

    AN EAP PATIENT EXPERIENCED A MEDICAL EMERGENCY AND HOSPITALIZATION OVER A WEEKEND. THE PATIENT BEGAN TO EXPERIENCE PROGRESSIVELY WORSENING SYMPTOMS OF HYPOCALCEMIA AND PROCEEDED TO THE EMERGENCY ROOM WHERE SHE WAS ADMINISTERED FORTEO (WHICH SHE HAD PREVIOUSLY BEEN ON VIA INFUSION PUMP). SHE WAS DISCHARGED FEELING BETTER THE FOLLOWING DAY. THE PATIENT HAD BEEN COMPLETELY OFF FORTEO AND IS ON 36 MCG/D TRANSCON PTH. SHE HAD BEEN INJECTING WITHOUT ISSUES FOR TWO WEEKS UNTIL THIS EVENT. SHE STATED THAT SHE TRIED TO ADMINISTER TWO SEQUENTIAL INJECTIONS, POSSIBLY FROM THE SAME PEN: AFTER THE FIRST INJECTION, THE PATIENT DID NOT THINK THE PEN INJECTED THE FULL DOSE AND BLAMED THE NEEDLE. AFTER THE SECOND INJECTION, THE PATIENT RECEIVED THE DRUG BUT MAY ALSO HAVE NOT BEEN A COMPLETE DOSE. THE PATIENT NOTED THAT AFTER THE SHOT, SHE FOUND THAT THE NEEDLE WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2475150 CLICKFINE AP 31GX5MM ASCENDIS 4'500ER PEN NEEDLE FMI YPSOMED AG CLICKFINE AP 31GX5MM ASCENDIS 4'500ER 221399-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization