BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4828013 · Received June 9, 2015

    Report

    Report Number
    3004209178-2015-63946
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    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. 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE WAS GETTING NO DELIVERY ALARMS ON THE INSULIN PUMP. CUSTOMER STATED THAT HE TRIED TO BOLUS AND RECEIVED A NO DELIVERY ALAR. CUSTOMER'S BLOOD GLUCOSE WAS 365 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER PERFORMED A 5.0 UNIT FIXED PRIME AND THE INSULIN DID NOT EXIT. CUSTOMER REPORTED THAT THE INSULIN EXITS WITH MANUAL PRIME. CUSTOMER STATED THAT ALTHOUGH THE INSULIN EXITED, IT WAS NOT COMING OUT LIKE IT SHOULD. CUSTOMER STATED THAT IT WAS SPORADIC DROPS AND IT WAS NOT CONSISTENT. CUSTOMER WAS EXPLAINED THAT IF HE THOUGHT IT WAS NOT FLOWING RIGHT, IT WAS RECOMMENDED TO CHANGE IT OUT. CUSTOMER UNDERSTOOD AND WILL CHANGE OUT HIS ENTIRE SET AS SOON AS HE IS ABLE TO DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370671 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR