BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4090546 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-19174
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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.THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    A CRACKED RESERVOIR TUBE LIP, CRACKED DISPLAY WINDOW, MINOR SCRATCHES ON THE DISPLAY WINDOW, AND A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS WERE NOTED DURING THE VISUAL INSPECTION. NO BUTTON ERROR ALARM WAS NOTED. ALL OF THE BUTTONS FUNCTIONED PROPERLY. HOWEVER, CORRODED KEYPAD TRACES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S MOTHER REPORTED SHE WAS NOT SURE WHAT HAPPEN TO THE DEVICE PRIOR TO ALARM SINCE CUSTOMER HAD THE DEVICE WITH HIM. CUSTOMER REVERTED TO SPEAR DEVICE. CUSTOMER'S MOTHER DID NOT KNOW CUSTOMER'S BLOOD GLUCOSE LEVEL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570253 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754CMS

    Patients

    Seq Age Sex Outcome Treatment
    1