BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3934350 · Received July 15, 2014

    Report

    Report Number
    2032227-2014-03599
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED HIGH PITCHED NOISE OR BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST AND SELF TEST. THE INSULIN PUMP ALARMED FOR A RESET ERROR AFTER A BATTERY CHANGE DUE TO A CRACKED SOLDER JOINT. THE INSULIN PUMP HAD INTERMITTENT ACT BUTTON RESPONSE DUE TO FLATTENED DOME SWITCHES. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A BROKEN RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND A MISSING 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 IS NOT WORKING PROPERLY. CUSTOMER'S FATHER STATED THAT THE INSULIN PUMP IS MAKING A HIGH PITCH ALARM AND NONE OF THE BUTTONS ARE WORKING. THE BATTERY WAS REMOVED AND REINSERTED AFTER TWO HOURS. THE INSULIN PUMP WORKED FINE. THE ALARM HISTORY HAD MULTIPLE ALARMS. THE BLOOD GLUCOSE READING WAS 174 MG/DL. CUSTOMER KEEPS THE INSULIN PUMP IN HER POCKET. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412609 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR