BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4111474 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27629
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH PROTRUDED LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP WAS ALSO RECEIVED WITHIN OPERATING CURRENTS IN SPECIFICATION AND NO UNEXPECTED FAILED BATTERY TEST. THE INSULIN PUMP HAS INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACE AND NUMBERS DO NOT RAMP UP ON ITS OWN OR SCROLL BAR MOVING WITH NO INPUT. NO MOISTURE DAMAGE ELECTRONIC ASSEMBLY. THE INSULIN PUMP HAS SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED, CRACKED RESERVOIR TUBE LIP AND RESERVOIR TUBE CRACKED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. CUSTOMER STATED THAT THEY HAD BEEN JUMPED INTO A POOL WHILE STILL ATTACHED TO THE DEVICE AND FLUID IS TRAPPED BEHIND THE DISPLAY SCREEN. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590636 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR