BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3945793 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87951
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    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

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION; OFF NO POWER ALARM FUNCTIONED PROPERLY AND PASSED SELF TEST. NO UNEXPECTED MISSING SEGMENTS, PARTIAL DISPLAY ANOMALY NOTED. THE INSULIN PUMP HAS CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW AND SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PARTIAL SCREEN AND STATED THAT THE DOWN BUTTON ON THE INSULIN PUMP IS UNRESPONSIVE. THE PARTIAL DISPLAY WAS RESOLVED WITH NEW BATTERIES. CUSTOMER STATED THAT THE SCREEN OF THE INSULIN PUMP LOOKS CLOUDY AND IT MAY BE EXPOSED TO MOISTURE. CUSTOMER ALSO MENTIONED THAT THE LAST BATTERY ONLY LASTED FOUR TO FIVE DAYS. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 160 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425697 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR