BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4151615 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34657
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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 HAD OPERATING CURRENTS IN SPECIFICATION. NO UNEXPECTED FAILED BATTERY TEST ALARM WAS NOTED. THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TESTS. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, A BROKEN BELT CLIP SLOT, AND A CRACKED RESERVOIR TUBE LIP. NO BATTERY OUT LIMIT ALARM WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT HE WAS TRYING TO BOLUS AND THE NUMBERS KEPT SCROLLING. CUSTOMER ALSO STATED THAT THE INSULIN WAS BEING DELIVERED. CUSTOMER STATED THAT HE REMOVED THE RESERVOIR TO KEEP FROM WASTING THE INSULIN AND GETTING TOO MUCH. CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE LEVELS WERE RUNNING HIGH A FEW DAYS AGO BECAUSE HIS BODY HAS SITES THAT DO NOT ABSORB INSULIN. CUSTOMER STATED THAT HE WENT UP TO 600 MG/DL AND STAYED THERE FOR APPROXIMATELY 6 HOURS BEFORE THEY BEGAN TO COME DOWN. CUSTOMER REPORTED THAT HE GOT LEG CRAMPS AND HAD TO DRINK SOME JUICE TO GET RID OF IT. CUSTOMER ALSO GOT A FAILED BATTERY TEST WHEN HE PLACED THE BATTERY BACK IN THE PUMP. CUSTOMER CHANGED THE BATTERY AND GOT THE BATT OUT LIMIT SINCE THE BATTERY WAS OUT FOR ABOUT 30 MINUTES. INSULIN PUMP WILL NEED TO BE REPLACED BASED ON THE KEYPAD BEING UNRESPONSIVE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633144 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR