BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984496 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90338
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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 CALLED IN TO REPORT THAT THE CUSTOMER HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE. THERE WAS A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE 3 WEEKS AGO. THE CUSTOMER WAS TREATED AND RELEASED. CUSTOMER'S MOTHER ASKED FOR ASSISTANCE WITH INSERTING THE INFUSION SET. ASSISTANCE WAS PROVIDED. THE INSULIN PUMP REQUIRED A NEW BATTERY AND FUNCTIONED PROPERLY AFTER THE BATTERY WAS REPLACED. NO ADDITIONAL ASSISTANCE NEEDED. BLOOD GLUCOSE READING AT THE TIME WAS 478 MG/DL. THE CUSTOMER HAS BEEN TREATED WITH MANUAL INJECTION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460255 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization