BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3112613 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93488
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 21, 2013
    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

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON KEYPAD TRACE. NO BUTTON ERROR ALARMS OCCURRED.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED TO REPORT HIGH BLOOD GLUCOSE. THE CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 299 MG/DL. THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER STATED THAT HE IS DEHYDRATED, KETONES, VOMITING AND DEPLETING POTASSIUM LEVELS. THERE WAS A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER HAD KETONES. HCP STATED DEHYDRATION AND POSSIBLE STOMACH VIRUS. CUSTOMER WAS HOSPITALIZED FOR THREE DAYS AND WAS GIVEN EXTENSIVE AMOUNTS OF FLUIDS, MEDICATION FOR VOMITING AND POTASSIUM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212663 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization