BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972158 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05129
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED AN INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM. INSULIN PUMP PASSED DISPLACEMENT TEST, OPERATING CURRENTS, SELF TEST, OFF NO POWER, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. NO FAILED BATTERY ALARM. INSULIN UNIT RECEIVED WITH ADDRESS LABEL PEELING, MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, BROKEN RESERVOIR TUBE LIP, MISSING END CAP STICKER AND MISSING RESERVOIR TUBE O-RING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ALARM AND A BATTERY FAILED ALARM. THE BLOOD GLUCOSE READING WAS 200 MG/DL. CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THIS ALARM. SHE ALSO REPORTED THAT THE STICKER ON THE BACK OF THE INSULIN PUMP WAS COMING OFF. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448288 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR