BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4810023 · Received June 1, 2015

    Report

    Report Number
    3004209178-2015-61064
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    March 14, 2015
    Report Date
    May 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATES OF THE EVENT PROVIDED WITH THE INITIAL REPORT WERE INCORRECT. THE CORRECT DATES HAVE BEEN PROVIDED WITH THIS REPORT.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA A FOLLOW UP PHONE CALL THAT HE HAD BEEN HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS ON (B)(6) 2015. THE CUSTOMER'S BLOOD GLUCOSE WAS OVER 800 MG/DL. THE CUSTOMER NOTED THAT HE HAD SURGERY ON HIS ARM ON (B)(6) 2015. HE WENT HOME THAT SAME DAY AND STOPPED TAKING HIS MEDICATIONS THE FOLLOWING DAY BECAUSE HE FELT WEAK. HE STATED THAT HE GOT DIZZY AND FELL. HE WOKE UP TO FIND THAT HIS FATHER AND EMERGENCY MEDICAL SERVICES WERE PRESENT. THE CUSTOMER STATED THAT HE WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF THE 911 CALL. HE STATED THAT HE WAS NOT OFF THE INSULIN PUMP PRIOR TO THE EVENT BUT HAD BEEN TAKEN OFF OF THE INSULIN PUMP WHILE IN THE HOSPITAL TWO DAYS PRIOR FOR HIS SURGERY. HE WAS HOSPITALIZED FOR 4 DAYS AND REPORTED THAT HIS BLOOD GLUCOSE HAD BEEN FINE SINCE. HE DID NOT KNOW THE CAUSE OF HIGH BLOOD GLUCOSE AND DECLINED TROUBLESHOOTING ASSISTANCE FOR THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353201 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization