BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6028077 · Received October 13, 2016

    Report

    Report Number
    2032227-2016-29827
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 22, 2016
    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
    WA
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER BLOOD GLUCOSE DROPPED TO 47 MG/DL. THE PATIENT TREATED WITH FOOD. TROUBLESHOOTING WAS DECLINED FOR THE LOW BLOOD GLUCOSE. THE PATIENT ALSO MENTIONED THAT HER SENSOR GLUCOSE WAS 47 MG/DL AS WELL, BUT THE THRESHOLD SUSPEND FEATURE DID NOT ACTIVATE AND HER INSULIN PUMP CONTINUED ITS NORMAL DELIVERY. TROUBLESHOOTING DID NOT OCCUR FOR THE INSULIN PUMP DUE TO KEY ISSUES. NO PRODUCTS WERE RETURNED FOR ANALYSIS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679496 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other