BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4132042 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31460
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. THERE WERE NO UNEXPECTED BATTERY ANOMALIES NOTED. THE UNIT ALARMED A21 AFTER A BATTERY CHANGE DUE TO A BROKEN SOLDER JOINT ON C13 I/B. THE UNIT WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE WHICH WAS DUE TO CORRODED KEYPAD TRACES. THE UNIT WAS RECEIVED WITH MINOR SCRATCHES ON THE LCD WINDOW, CRACKS ON THE RESERVOIR TUBE LIP, CRACKS ON THE BATTERY TUBE THREADS, AND THE END CAP STICKER WAS MISSING.

    Additional Manufacturer Narrative · 1

    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 RECEIVING AN EXCESSIVE NO DELIVERY ALARM. THE CUSTOMER ALSO REPORTED RECEIVING A BUTTON ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 224 MG/DL. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611810 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR