BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3974080 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88923
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND DISPLAY WINDOW. MINOR SCRATCHED DISPLAY WINDOW 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 A CRACK ON THE LOWER LEFT CORNER OF THE SCREEN AND STATED THAT THE UPPER LEFT CORNER OF THE INSULIN PUMP'S SCREEN IS BUBBLING UP. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 206 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450770 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR