BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4123030 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29565
    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
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT RECEIVED A NO DELIVERY ALARM AND MOTOR ERROR ALARM. BLOOD GLUCOSE VALUE IS 170 MG/DL. CUSTOMER STATED THAT THE MOTOR ERROR ALARM OCCURRED WHEN TRYING TO FILL THE TUBING. CUSTOMER DID NOT RECALL ANY EVENTS LEADING TO THE ALARMS. CUSTOMER DOES NOT USE THE SENSOR FEATURE AND IS ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED THAT THERE ARE LARGE AIR BUBBLES INSIDE THE RESERVOIR AND THAT HE FELT LIKE THE INFUSION SETS THAT HE IS CURRENTLY USING ARE NOT STICKING CORRECTLY. NO TROUBLESHOOT PERFORMED FOR NO DELIVERY; DEVICE IS BEING REPLACED DUE TO THE MOTOR ERROR ALARM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600738 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A HG003FB

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR UNOMEDICAL INSULIN INFUSION SET