BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6189831 · Received December 20, 2016

    Report

    Report Number
    2032227-2016-51004
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP RECEIVED WITH MISSING SEGMENTS/PARTIAL DISPLAY DUE TO CRACKED AND BLEEDING LCD GLASS. UNABLE TO PERFORM ANY TESTS DUE TO DAMAGE OF LCD DISPLAY. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED CASE NEAR DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON DISPLAY WINDOW NOTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE PHYSICAL DAMAGE OF INSULIN PUMP. CUSTOMER REPORTED THAT THERE WAS A CRACK ON DISPLAY SCREEN AND IT WAS BLUE. CUSTOMER REPORTED THAT DAMAGE WAS CAUSED BY PUMP LEANING AGAINST AN OBJECT. IT WAS REPORTED THAT DISPLAY SCREEN HAD MISSING SEGMENTS AND WAS NOT LEGIBLE. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842155 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR