BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3710993 · Received March 31, 2014

    Report

    Report Number
    3004209178-2014-83130
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    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. 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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED IN WITH A CRACKED AND BLEEDING LCD. THE DEVICE WAS ALSO RECEIVED WITH A CONSTANT TONE DUE TO A LOOSE AND BROKEN COMPONENT ON THE INTERFACE BOARD AND MOTHERBOARD. UNABLE TO CONFIRM THE BLANK OR FROZEN DISPLAY DUE TO THE BROKEN LCD. A DENT AROUND THE CASE WAS ALSO NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAS A FROZEN SCREEN. CUSTOMER HAS CHANGED THE BATTERIES. CUSTOMER CANNOT READ THE LCD SCREEN. CUSTOMER STATED THAT THE BUTTONS ARE UNRESPONSIVE AND THE SCREEN IS TOTALLY BLANK. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192150 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR