BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4161941 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36116
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A SCRATCH ON THE SCREEN AND IT IS INDENTED IN THE GLASS BOX. CUSTOMER STATED THAT IT HIT AGAINST THE TABLE AND MESSED UP THE GLASS BOX. CUSTOMER WAS SITTING DOWN IN A CHAIR AND GOT UP AND SCRATCHED THE SCREEN WITH THE TABLE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 150 MG/DL. CUSTOMER STATED THAT THE PUMP WAS WORKING FINE AND THE SCRATCH IS JUST ON THE SURFACE. CUSTOMER WAS ADVISED THAT SHE CAN STILL USE THE PUMP AND TO MONITOR THE PUMP. CUSTOMER STATED THAT IT IS NOT A CRACK, ONLY A SCRATCH ON THE SCREEN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644899 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR