BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6098061 · Received November 12, 2016

    Report

    Report Number
    2032227-2016-41827
    Event Type
    Malfunction
    Date Received
    November 12, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 22, 2016
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEIR INSULIN PUMP ALARMED TWICE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 88 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS INFORMED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. THE CUSTOMER SENT THE PRODUCT BACK FOR ANALYSIS. A REPLACEMENT INSULIN PUMP WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749042 530G INSULIN PUMP OZO OZO MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR