BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4260174 · Received November 18, 2014

    Report

    Report Number
    2032227-2014-54489
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. 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'S MOTHER REPORTED THAT THE INSULIN PUMP HAD OFF NO POWER AND ALARMED SPI TO MOTOR PIC COMMUNICATION ERROR. CUSTOMER STATED THAT HER SON'S INSULIN PUMP NEEDED BATTERY CHANGED AND PUT IN TWO DIFFERENT BATTERIES AND GOTTEN OFF NO POWER AND SPI TO MOTOR PIC COMMUNICATION ERROR. CUSTOMER SATED THAT THEY RECEIVED LOW BATTERY ALERT PRIOR TO THE OFF NO POWER. CUSTOMER'S BLOOD GLUCOSE WAS 150 MG/DL. TROUBLESHOOTING WAS DONE. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED THE CUSTOMER TO DISCONTINUE USING THE INSULIN PUMP DUE TO THE INSULIN PUMP STILL NOT POWERING ON AFTER SEVERAL BATTERY CHANGES AND SPI TO MOTOR PIC COMMUNICATION ERROR IS OCCURRING. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746032 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR