BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4881779 · Received July 1, 2015

    Report

    Report Number
    2032227-2015-20694
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 170 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT NONE OF THE BUTTONS WERE WORKING. CUSTOMER ALREADY TOOK THE BATTERY OUT AND PUT IT BACK BUT IT IS NOT WORKING. CUSTOMER JUST HAD THE PUMP TUCKED IN HIS BOXERS AND DID NOT KNOW IF THE BUTTONS WERE BEING PUSHED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. CUSTOMER WILL NOT BE REPLACING HIS PUMP BECAUSE HE ALREADY HAS A REPLACEMENT PUMP IN HIS RANCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428541 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR