BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4122995 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29531
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 CALLED FOR ASSISTANCE CHANGING HER INFUSION SET. CUSTOMER'S BLOOD GLUCOSE WAS 202 MG/DL. SHE STATED THERE WERE AIR BUBBLES IN THE RESERVOIR ABOUT THE SIZE OF A PEA. CUSTOMER ALSO MENTIONED HE HAD TWO FAULTY RESERVOIRS. HE COULD NOT PUSH THE PLUNGER ONCE THE RESERVOIR WAS FILLED ON BOTH OF THEM. THE RESERVOIRS ARE BEING REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600361 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC MINIMED MMT-326A HG0629D

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR