BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3974285 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88897
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO A BATTERY TUBE CONNECTOR NOT PROPERLY PLUGGED IN. THE LOW BATTERY ALARM, OFF NO POWER ALARM, BAD BATTERY ALARM AND FAILED BATTERY TEST ALARM COULD NOT BE VERIFIED DUE TO THE BLANK DISPLAY. THE DISPLACEMENT, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TESTS COULD NOT BE PERFORMED DUE TO THE BLANK DISPLAY. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    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 ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THE INSULIN PUMP IS ALARMING. THE BLOOD GLUCOSE READING IS 600 MG/DL. THE INSULIN PUMP WILL NEED TO BE REPLACED SINCE THE BATTERY ALARM FAILED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449980 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR