BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3882443 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-85919
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED ABOUT HAVING INSULIN LEAK OUT OF THE RESERVOIR. SHE STATED THAT THERE WAS INSULIN IN THE RESERVOIR COMPARTMENT AND HAS RECENTLY EXPERIENCE HIGH BLOOD GLUCOSE LEVELS. CUSTOMER STATED SHE REACHED A BLOOD GLUCOSE OF 511MG/DL, TREATED WITH MANUAL INSULIN INJECTION AND CURRENT BLOOD GLUCOSE IS 211MG/DL. DURING TROUBLESHOOT, IT WAS IDENTIFIED THAT THE RESERVOIR LOT NUMBER WAS AN AFFECTED LOT. RESERVOIRS HAD TO BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357538 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8486688

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR