BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3984328 · Received August 6, 2014

    Report

    Report Number
    2032227-2014-05931
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED BUTTON ERROR DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, AND CRACKED RESERVOIR TUBE LIP.

    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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A COSTUMER CALLED COMPLAINING ABOUT A BUTTON ERROR ALARM SETTING OFF ON THEIR INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 300 MG/DL. THE CAUSE OF THE BUTTON ERROR ALARM IS UNKNOWN. THE CUSTOMER WAS INFORMED THAT THE PUMP MUST BE REPLACED AND ALSO WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460582 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-522LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1