BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974374 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05350
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER CALLED TO REPORT THAT HER DAUGHTER WAS RECEIVING A MOTOR ERROR ALARM AND VIBRATIONS ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF THE EVENT WAS UNKNOWN. WE ADVISED THE CUSTOMER THAT WE WOULD NEED TO DO TROUBLESHOOTING ON THE PUMP AND TO HAVE HER DAUGHTER CALL IN WHEN SHE WAS ABLE TO. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451217 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR