BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3982016 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89994
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 ABOUT 2 MONTHS PRIOR; THE INCIDENT WAS ALREADY REPORTED TO THE FDA. THE CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP NOW READ "YOU HAVE DIABETES, CALL 911." THE BLOOD GLUCOSE READING WAS 83 MG/DL AT THE TIME OF THE ALARM. ADVISED THAT THE ALARM WAS A THRESHOLD SUSPEND ALARM. THE CALLER STATED THAT IT WAS A DIFFERENT BEEP VOLUME THAN NORMAL. THE BLOOD GLUCOSE READING ROSE TO 108 MG/DL. ASSISTED THE CUSTOMER WITH CHECKING ALERT TYPE VOLUME. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458387 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization