BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4123031 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29566
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 3, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    EVALUATED ONE OPENED/USED RESERVOIR. PERFORMED VISUAL INSPECTION AND FAILED PER SPEC. DUE TO FOUND SNAP-CAP DETACHED FROM RESERVOIR'S BARREL, SNAP-CAP ATTACHED TO TRANSFER GUARD.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN SHE TRIES TO CONNECT THE INFUSION SET AND THE RESERVOIR IT WOULD GET STUCK AND NOT DELIVER INSULIN. CUSTOMER STATED THAT SHE RECEIVED A NO DELIVERY ALARM DURING MANUAL PRIME, SHE CHANGED OUT TWICE THE ENTIRE SET AND ALARM WAS RESOLVED. BLOOD GLUCOSE VALUE IS 80 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600442 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A HG03Y87

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR