BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3980719 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-05953
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO BUTTON ERROR ALARM WAS NOTED. ALL OF THE BUTTONS FUNCTIONED PROPERLY. HOWEVER, MOISTURE DAMAGE WAS FOUND ON THE KEYPAD TRACES. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, A STAINED ADDRESS AND SERIAL NUMBER LABEL, MINOR SCRATCHES ON THE DISPLAY WINDOW, AND A STAINED END CAP STICKER.

    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 WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 150 MG/DL. THE CUSTOMER CHANGED THE BATTERY BUT THE BUTTON ERROR ALARM RESUMED. THE CUSTOMER STATED THAT THE INSULIN PUMP MIGHT HAVE GOTTEN SQUIRTED WITH THE WASTER PISTOL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458596 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR