BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4002450 · Received August 12, 2014

    Report

    Report Number
    2032227-2014-07416
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 13, 2014
    Report Date
    July 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP UP ARROW BUTTON DID NOT RESPOND DUE TO CORRODED KEYPAD TRACE. UNABLE TO VERIFY BATTERY OUT LIMIT ALARM DUE TO NO BUTTON RESPONSE. INSULIN PUMP HAD MOISTURE DAMAGE ON ELECTRONICS, MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS AND BROKEN RESERVOIR TUBE LIP.

    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. CUSTOMER STATED THAT THE BUTTONS ON THE INSULIN PUMP WERE UNRESPONSIVE. CUSTOMER ALSO STATED THAT HE HAD RECENTLY FALLEN INTO WATER WHILE WEARING THE INSULIN PUMP. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 150 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477551 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS A000093830

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR