BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4032447 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-97373
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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. 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 HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 439 MG/DL. HE TREATED WITH A MANUAL INJECTION AND BROUGHT IT DOWN TO 400 MG/DL. CUSTOMER ALSO REPORTED THAT HE RECEIVED A NO DELIVERY ALARM. CUSTOMER WAS ASSISTED IN PERFORMING A 5 UNIT FIXED PRIME AND STATED THAT INSULIN DID EXIT. CUSTOMER WAS ADVISED TO DISCONNECT AND RECONNECT THE TUBING AND RESERVOIR AND MANUALLY PUSH INSULIN VERY SLOWLY THROUGH THE TUBING WITH THE PLUNGER. HE STATED THAT INSULIN DID NOT EXIT AND THAT HE EXPERIENCED RESISTANCE WITH THE PLUNGER PUSH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514709 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H8889359

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR