BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4161955 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36133
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4). REFERENCE MANUFACTURER REPORT NUMBER: 2032227-2014-33808.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CALIBRATING ERRORS WITH HER SENSORS. THE CUSTOMER ALSO REPORTED INACCURATE READINGS BETWEEN HER SENSOR GLUCOSE AND BLOOD GLUCOSE. SHE STATED HER SENSOR GLUCOSE WAS 300 MG/DL AND BLOOD GLUCOSE WAS 44 MG/DL. SHE ALSO STATED HER INSULIN PUMP WENT INTO THRESHOLD SUSPEND BECAUSE OF THE INACCURATE READINGS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644238 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR