BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4163510 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36401
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    July 26, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM DURING TESTING. WE WERE UNABLE TO PERFORM ANY TESTS DUE TO BUTTONS UNRESPONSIVE. THE INSULIN PUMP WAS RECEIVED WITH BROKEN BATTERY TUBE THREAD, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, CRACKED ON DISPLAY WINDOW, MISSING END CAP STICKER, AND MINOR SCRATCHES ON DISPLAY WINDOW NOTED. NO MOISTURE DAMAGE NOTED ON ELECTRONICS ASSEMBLY.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED A BUTTON ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP MAY HAVE RECENTLY BEEN EXPOSED TO SWEAT. BLOOD GLUCOSE LEVEL WAS 116 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639150 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR