BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3945906 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-88015
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNABLE TO VERIFY FOR BATTERY OUT OF LIMIT OR WEAK BATTERY ALARM DUE TO FAILED BATTERY TEST ALARM. NO BLANK DISPLAY NOTED. A GOOD BATTERY CAP WAS USED AND THE INSULIN PUMP FUNCTIONED PROPERLY. MINOR SCRATCHED DISPLAY WINDOW NOTED. NO DAMAGE INSIDE PUMP NOTED.

    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 SEVERAL ERROR ALARMS ON THE INSULIN PUMP, INCLUDING WEAK BATTERY, FAILED BATTERY, AND BATTERY OUT LIMIT. CUSTOMER ALSO REPORTED A BLANK DISPLAY THAT DID NOT RETURN AFTER A BATTERY CHANGE. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 263 MG/DL AND HAS TREATED WITH A MANUAL INJECTION. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425445 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR