BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3812899 · Received May 15, 2014

    Report

    Report Number
    2032227-2014-02358
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 6, 2016
    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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. UNIT WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS AND BATTERY TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO SEIZURE AND LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING WAS 31 MG/DL AT THE TIME OF HOSPITALIZATION. CALLER STATED THAT THE CUSTOMER'S INSULIN PUMP WAS MALFUNCTIONING, IT WAS ALARMING MOTOR ERROR AND TURNED OFF BY ITSELF. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291151 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization