BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4142124 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33152
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A BUTTON ERROR DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL REGISTERED PROPERLY IN THE BOLUS HISTORY. NO BOLUS HISTORY ANOMALY WAS NOTED. NO RESET ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH A PEELING, BUT NOT WORN OR FADED, ADDRESS AND SERIAL NUMBER LABEL, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER.

    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 RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP AND THE BOLUS HISTORY WAS RECORDING WRONG FOR ABOUT A MONTH. IT WAS NOTED THAT THE DATE ON THE INSULIN PUMP WAS WRONG. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 82 MG/DL AND HAS TREATED WITH A BOLUS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621121 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR