BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4241225 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50079
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HIS INSULIN PUMP ALARMED OFF NO POWER. HE HAD JUST SHOWERED IN THE MORNING AND WAS TRYING TO DELIVER A BOLUS FOR BREAKFAST WHEN THE DEVICE SAID OFF NO POWER. INSERTING A NEW BATTERY DOES NOT RESOLVE THE ISSUE. CUSTOMER'S BLOOD GLUCOSE WAS 125 MG/DL. CUSTOMER STATED THE BATTERY CONTACTS WERE PRETTY DIRTY. CUSTOMER CLEANED THE CONTACTS AND INSERTER A NEW BATTERY AND THE DEVICE TURNED BACK ON. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE. A REPLACEMENT BATTERY CAP WAS SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723377 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR