BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4822569 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-63203
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE WAS 470 MG/DL. THE CUSTOMER TRIED TO BOLUS IN ORDER TO TREAT FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER'S MOST RECENT BLOOD GLUCOSE WAS OVER 600 MG/DL. HE COMPLAINED OF DEHYDRATION AND FEELING PARCHED. HE DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE HOSPITALIZATION. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE, REMOVE, REWIND, AND REINSERT THE RESERVOIR, THEN RUN A MANUAL PRIME; INSULIN EXITED AT THE QUICK RELEASE. HE NOTED THAT THE DRIVE SUPPORT CAP WAS RECESSED. HE OBSERVED A SMALL AIR BUBBLE ALONG THE INFUSION SET. NO BENT INFUSION SET CANNULA WAS FOUND. HE DECLINED TO PERFORM THE HIGH PRESSURE TEST. HE WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET, RESERVOIR AND INSULIN AND TO TREAT PER DOCTOR'S INSTRUCTIONS. HE ADVISED THAT HE WOULD MONITOR THE ISSUE AND CALL BACK IF THE HIGH BLOOD GLUCOSE PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365167 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization