BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4170426 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37796
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    July 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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 REPORTED THAT THEY HAD TWO BARS ON THE BATTERY AND THE INSULIN PUMP SUDDENLY WENT BLANK AND THE BATTERY HAD TO BE REPLACED. THE DISPLAY WAS NOTED TO RETURN WITH THE INSERTION OF A NEW BATTERY. CUSTOMER STATED THAT THERE WERE COUPLE MARKS ON THE SCREEN OF THE INSULIN PUMP. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651886 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR