BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3831224 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84970
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED TWO OPENED USED RESERVOIRS. INSPECTED THE RESERVOIRS O-RINGS/STOPPER GROOVE FOR ANOMALIES. NONE WERE FOUND. RAN BASAL, BOLUS LEAKING TEST AS FOLLOWS: RESERVOIRS FILLED WITH DILUENTS, AND CONNECTED TO A NEW INFUSION SET. INSTALLED RESERVOIR AND CONNECTOR INTO AN INSULIN PUMP AND THE RESERVOIR DID NOT LEAK AND ALSO WAS NOT OCCLUDED.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS EXPERIENCING A LEAKING RESERVOIR AND HAD A BLOOD GLUCOSE LEVEL OF 101 MG/DL. PRODUCT IS BEING RETURNED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308775 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR