BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4103604 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26456
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO DELIVERY ALARMS WERE RECEIVED ON THE CUSTOMER'S INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE WAS 421 MG/DL, WHICH WAS TREATED WITH 10 UNITS OF INSULIN. THE CUSTOMER PERFORMED A 5.0 UNIT FIXED PRIME. INSULIN EXITED AND THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER WAS THEN ADVISED TO REMOVE THE RESERVOIR FROM THE INSULIN PUMP AND TO DISCONNECT AND RECONNECT THE RESERVOIR AND INFUSION SET AT THE TUBING CONNECTOR, AND PUSH INSULIN THROUGH THE TUBING. INSULIN DID NOT EXIT THE TUBING AND THERE WAS GREATER THAN NORMAL RESISTANCE WITH THE PLUNGER PUSH. IT WAS EXPLAINED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE INFUSION SET AND RESERVOIR, CAUSING THE NO DELIVERY ALARM. IT WAS ADVISED TO REPLACE INFUSION SET AND RESERVOIR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582293 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR UNOMEDICAL INSULIN INFUSION SET