BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974003 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89009
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED. NO BUTTON RESPONSE DUE TO MOISTURE DAMAGE NOTED ON THE KEYPAD TRACES. UNABLE TO PERFORM THE PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION OR THE EXCESSIVE NO DELIVERY ALARM TESTS. NO MOISTURE DAMAGE NOTED ON ELECTRONIC ASSEMBLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER'S FATHER REPORTED THAT THE KEYPAD ON THE CUSTOMER'S INSULIN PUMP BECAME UNRESPONSIVE. CUSTOMER HAD TAKEN A SHOWER, AND WENT TO DELIVER A BOLUS, AND THE KEYPAD DID NOT RESPOND. HE REPORTED THAT CUSTOMER WAS IN SPAIN AT THE TIME AND EXPERIENCING MANY HIGH BLOOD GLUCOSE LEVELS DUE TO THE HEAT AND SWEATING. THE BLOOD GLUCOSE READING WAS 330 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450635 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR