BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5115220 · Received September 30, 2015

    Report

    Report Number
    2032227-2015-51538
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 12, 2015
    Report Date
    September 12, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HIS INSULIN PUMP HAD AN UNEXPECTED RESTART. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 139 MG/DL. THE CUSTOMER STATED THAT THE ALARM ON HIS SCREEN WAS SOLID, AND WHEN HE TRIED TO CLEAR THE ALARM THE PUMP BEGAN TO REWIND. THE CUSTOMER CONFIRMED THAT THE UNEXPECTED RESTART DID NOT OCCUR SHORTLY AFTER A BATTERY CHANGE, AND THAT IT HAPPENED DURING NORMAL USE. THE CUSTOMER MENTIONED THAT HIS WIFE MIGHT HAVE BEEN LAYING ON THE PUMP. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP AND REVERT TO A MEDICALLY PRESCRIBED BACK-UP PLAN OR SEEK ASSISTANCE FROM HIS HEALTH CARE PROFESSIONAL. NO PRODUCTS WERE SHIPPED OR RETURNED; THE CUSTOMER WANTED TO BUY A NEW PUMP ON HIS OWN AND NOT THROUGH INSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644220 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR