BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3100687 · Received May 8, 2013

    Report

    Report Number
    2032227-2013-01762
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 14, 2013
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE INSULIN PUMP PASSED FUNCTIONAL TESTINGS INCLUDING DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. THE INSULIN PUMP WAS RECEIVED WITH NO VIBRATION DURING SELF TEST.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER CALLED TO REPORT A HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING WAS 70 MG/DL AFTER MANUAL INJECTION. CUSTOMER HAD A SEIZURE. CALLER STATED THAT CUSTOMER GAVE HIMSELF TOO MUCH INSULIN AND THE TIME AND DATE ARE ONE DAY AHEAD. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200929 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization