BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123538 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29740
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTONS RESPONSE ON THE ESCAPE BUTTON DUE TO CORRODED KEYPAD TRACES AND SEVERELY CORRODED BATTERY TUBE THREAD. NO UNEXPECTED BUTTON ERROR ALARM NOTED. THE INSULIN PUMP HAS MINOR SCRATCHES ON THE LCD WINDOW, CRACKED CAST AT THE LCD WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON THE RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS, BROKEN BATTERY CAP, MISSING END CAP STICKER AND STAINED ADDRESS SERIAL NUMBER LABEL.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THE INSULIN PUMP IS SQUIRTING INSULIN AND THE INSULIN PUMP IS ALARMING. THE BLOOD GLUCOSE READING IS 139 MG/DL. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602293 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR