BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2940016 · Received February 1, 2013

    Report

    Report Number
    2032227-2013-00443
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 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 ALL FUNCTIONAL TEST, INCLUDING PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD UNEXPLAINED HIGH BLOOD GLUCOSE. CUSTOMER WENT TO THE EMERGENCY ROOM TWICE AND WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE BOTH OF THE TIMES. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION THE FIRST TIME WAS OVER 400 MG/DL, THE SECOND TIME THE BLOOD GLUCOSE READING WAS 478 MG/DL. CALLER STATED THAT THE CUSTOMER HAD ABDOMINAL PAIN AND WAS VOMITING BOTH OF THE TIMES PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44263 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization