BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4052988 · Received September 2, 2014

    Report

    Report Number
    3004209178-2014-98388
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 HER DAUGHTER'S INSULIN PUMP ALARMED OFF NO POWER AND THEN SHUT DOWN. CUSTOMER'S BLOOD GLUCOSE IS 471 MG/DL. SHE IS TREATING WITH CORRECTIVE DOSES OF INSULIN. CUSTOMER DID NOT RECEIVE A LOW BATTERY ALERT BEFORE SHUTTING OFF. TROUBLESHOOTING FOUND NO ANOMALIES. CUSTOMER WAS ADVISED TO INSERT A FRESH ENERGIZER BATTERY AND MONITOR THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533674 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention