BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974059 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88931
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 30, 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
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS NOTED. TRACES OF CORROSION WERE NOTED AT ELECTRONIC AND MOTOR ASSEMBLIES PER VISUAL INSPECTIONS. CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE LIP, BATTERY TUBE THREADS AND MINOR SCRATCHED DISPLAY WINDOW.

    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

    CUSTOMER REPORTED DROPPING THE INSULIN PUMP IN WATER AND RECEIVING A BUTTON ERROR ALARM. CUSTOMER ALSO STATED THAT THE INSULIN PUMP WAS NOT READING THE BATTERIES. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 134 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450694 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR