BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4771026 · Received May 14, 2015

    Report

    Report Number
    2032227-2015-15657
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTS. THE INSULIN PUMP FUNCTIONED PROPERLY. HOWEVER, THE INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE NOTED DUE TO FLATTENED DOME SWITCH ON THE ESC BUTTON. THE INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE NOTED DUE TO FLATTENED DOME SWITCH ON THE ESC BUTTON. THE INSULIN PUMP ALSO HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED AND REPORTED HE WAS HOSPITALIZED WITH BLOOD GLUCOSE OF 29 MG/DL, AFTER THE CUSTOMER PASSED OUT AND HAD A LOW BLOOD GLUCOSE OF 25 MG/DL. THE CUSTOMER REPORTEDLY TREATED WITH FOOD. CUSTOMER STATED THE REASON FOR THE LOW BLOOD GLUCOSE WAS THAT THE INSULIN PUMP BUTTONS MALFUNCTIONED AND INSULIN WAS ACCIDENTALLY PUMPED. CUSTOMER FURTHER STATED HE HAD TO SMACK THE INSULIN PUMP ON THE TABLE TO GET IT TO WORK. NO SIGNIFICANT EVENTS WERE RECALLED LEADING UP TO THE KEYPAD ISSUES. IT WAS ADVISED THAT THE CUSTOMER DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. CUSTOMER WAS FURTHER ADVISED THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315246 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization