BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4792128 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58868
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 30, 2015
    Report Date
    May 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE ACT BUTTON AND UP ARROW BUTTONS DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE ON ELECTRONICS NOTED. THE INSULIN PUMP WAS MONITORED AND NO AUDIO BEEP ANOMALY NOTED. UNABLE TO VERIFY WEAK SIGNAL ALARM, BLOOD GLUCOSE METER NOW ALARM ANOMALY AND LOST SENSOR ALARM DUE TO UNRESPONSIVE BUTTONS. THE INSULIN PUMP HAS MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS AND 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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 VIA PHONE CALL THAT THERE IS A KEYPAD ANOMALY. THE BLOOD GLUCOSE READING IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334724 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR