BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841785 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02715
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    CUSTOMER'S MOTHER REPORTED THAT CUSTOMER WAS HAVING PROBLEMS WITH THE INSULIN PUMP. CUSTOMER'S MOTHER REPORTED THAT THE INSULIN PUMP DID NOT ALARM NO DELIVERY. CUSTOMER'S MOTHER STATED THAT DURING INFUSION SET THE CANNULA WOULD NOT INSERT TO THE BODY. CUSTOMER'S MOTHER WAS ADVISED THAT IT WAS POSSIBLE THAT THE DEVICE DID NOT ALARM NO DELIVERY SINCE THE INSULIN WAS STILL ABLE TO EXIT. CUSTOMER'S MOTHER REFUSED TROUBLESHOOTING FOR NO DELIVERY DUE TO HER NOT WANTING TO CHANGE INFUSION SET. BLOOD GLUCOSE LEVEL WAS 128 MG/DL. NO FURTHER INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319123 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR