BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3801019 · Received May 8, 2014

    Report

    Report Number
    2032227-2014-01806
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    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 STATED THAT HIS WIFE CALLED THE PARAMEDICS TWICE. CUSTOMER PASSED OUT DUE TO LOW BLOOD GLUCOSE. CUSTOMER WAS NOT TRANSPORTED TO HOSPITAL. THE LOW BLOOD GLUCOSE EVENTS HAPPENED OVER A YEAR AGO. CUSTOMER HAS EXPERIENCED LOW BLOOD GLUCOSE EVENT WITHOUT BEING HOSPITALIZED. CUSTOMER HAS HIGH BLOOD GLUCOSE AT THIS TIME; CUSTOMER TREATED WITH BOLUS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277925 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention