BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4140846 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-33186
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING WAS OVER 1100 MG/DL, AND HE WAS TREATED, THEN RELEASED AFTER 4 DAYS IN THE INTENSIVE CARE UNIT. THE CUSTOMER'S DOCTOR STATED THAT THE INSULIN PUMP WAS FUNCTIONING WELL BUT OBSERVED THAT THE INSERTION SITE WAS WHAT WAS CAUSING THE ISSUE. THE CUSTOMER HAD BEEN VOMITING AT THE TIME OF HOSPITALIZATION. HE STATED THAT HE MAY HAVE PUT THE INFUSION SET IN AT THE WRONG ANGLE AND WAS NOT GETTING INSULIN. PRIOR TO THE EVENT, HE NOTED THAT HE HAD BEEN FIGHTING A FLU VIRUS, AND WOKE UP VOMITING ASSUMING IT WAS THE FLU. THE BLOOD GLUCOSE READING WAS 500 MG/DL THE DAY BEFORE THE EMERGENCY ROOM VISIT. HE STATED THAT HE WAS SHOWING ENZYMES THAT INDICATED HE MAY HAVE HAD A HEART ATTACK. HE WAS WEARING THE INSULIN PUMP AT THE TIME OF ADMITTANCE AND STATED THAT HE LOVED THE INSULIN PUMP; TROUBLESHOOT WAS DECLINED SINCE THE DOCTOR ALREADY DID. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619694 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization