BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4203381 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43582
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE PER VARIANCE 5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF OVER 500 MG/DL. IT WAS REPORTED THAT THE CUSTOMER TREATED WITH MANUAL INSULIN INJECTIONS. THE CUSTOMER REPORTED HAVING ISSUES WITH THE SENSOR GLUCOSE LEVELS READING BEING DIFFERENT FROM THE BLOOD GLUCOSE LEVELS READING. THE CUSTOMER REPORTED THAT THE INSULIN PUMP INDICATED A SENSOR GLUCOSE READING OF 36 MG/DL WHERE THE ACTUAL BLOOD GLUCOSE LEVEL WAS WELL OVER 500 MG/DL. TROUBLESHOOTING WAS DONE. THE CUSTOMER ALSO REPORTED BEING HOSPITALIZED FOR CLOGGED ARTERIES. IT WAS ALSO REPORTED THAT THE INSULIN PUMP WAS PROGRAMMED TO BE SILENT FOR ALL ALARMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683263 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR