BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3933414 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-87055
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER MOTHER CALLED STATING CUSTOMER'S INSULIN PUMP HAS CONSTANTLY BEEN ALARMING WEAK SIGNAL AND LOST SENSOR. THE SENSOR READINGS HAVE BEEN MORE THAN A HUNDRED POINTS OFF. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 138 MG/DL. CUSTOMER RECEIVED A METER BLOOD GLUCOSE REMINDER, BUT CUSTOMER IGNORED IT BECAUSE THE DEVICE ALARMED CALIBRATION ERROR. CUSTOMER'S MOTHER DECLINED TO TROUBLE SHOOT BECAUSE CUSTOMER HAD TO GO TO BED. CUSTOMER CALIBRATES THREE TO FOUR TIMES A DAY. WEAK SIGNAL AND LOST SENSOR ALARMS WERE EXPLAINED TO CUSTOMER. CUSTOMER WAS ADVISED TO CALL BACK WHEN THE ISSUE OCCURS SO SHE CAN TROUBLE SHOOT. SHE WAS ALSO ADVISED TO CHANGE THE SENSOR IF THE ISSUE KEEPS HAPPENING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409270 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR