BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4801329 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-59935
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    April 23, 2015
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE SVN (B)(4) FOR RELATED DOCUMENTATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY EXPERIENCED DIABETIC KETOACIDOSIS WITH A HIGH BLOOD LEVEL GLUCOSE OF 667 MG/DL. THE CUSTOMER FELT SYMPTOMS OF NAUSEA AND VOMITING. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2015 AT 5 AM. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH THE INSULIN PUMP. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF HOSPITALIZATION. THE CUSTOMER STATED THEY HAD NO DELIVERY ALARMS FROM THEIR INSULIN PUMP LATELY. THE CUSTOMER ALSO COMPLAINED ABOUT BENT CANNULAS. CUSTOMER DOES NOT WANT TO RETURN THE RESERVOIR FOR ANALYSIS. THE CUSTOMER SENT THE INSULIN PUMP BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347624 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization