BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3882469 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-85940
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. CUSTOMER WAS ADMITTED TO INTENSIVE CARE UNIT, BLOOD GLUCOSE READING WAS 700MG/DL DURING THE HOSPITALIZATION. CUSTOMER WAS OFF THE PUMP AND TOOK MANUAL INJECTIONS DURING HER ADMISSION. CUSTOMER STATED WAS UNSURE IF SHE WAS GETTING ANY INSULIN. CUSTOMER WENT TO BED WITH 300MG/DL AND SET THE INSULIN TO DELIVER AFTER MIDNIGHT, SUPPOSE TO GET THE LONG TERM. CUSTOMER CHECK HER BLOOD GLUCOSE AND IT READ THE SAME. THE CUSTOMER'S SYMPTOMS OF HIGH BLOOD GLUCOSE WERE WEAK EYES AND FEELING TIRED. CUSTOMER THINKS HE'S GETTING AN ABSENCE OF NO DELIVERY ALARM. CUSTOMER HAD A BENT CANNULA. THE BLOOD GLUCOSE READING WAS 389MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357234 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization