BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3870701 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85619
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 19, 2014
    Report Date
    April 11, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION. THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE RESERVOIR CAN BE INSERTED AND REMOVED FROM RESERVOIR COMPARTMENT PROPERLY.

    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.

    Description of Event or Problem · 1

    CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 54 MG/DL. CUSTOMER WAS FEELING SICK THE PREVIOUS DAY. CUSTOMER DID NOT CHECK HIS BLOOD GLUCOSE LEVEL. CUSTOMER TREATED WITH GLUCOSE PILLS. THE CURRENT BLOOD GLUCOSE READING WAS 288 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER STATED THAT THE INSULIN PUMP FELL AT THE HOSPITAL AND HAS COSMETIC DAMAGE. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347938 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization