BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINISHED GOODS MATERIAL MASTER 1001

    MDR report key: 8662300 · Received June 3, 2019

    Report

    Report Number
    2032227-2019-10642
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THE SENSOR HAD INACCURATE READINGS THAT TRIGGERED THRESHOLD SUSPEND ALARM. THE CUSTOMER¿S BLOOD GLUCOSE VALUES WAS 114 MG/DL AND THE SENSOR GLUCOSE WAS 40 MG/DL. INSULIN DELIVERY WAS SUSPENDED DUE TO SENSOR VALUES. THE CUSTOMER WAS INFORMED THAT THEIR BLOOD GLUCOSE AND SENSOR GLUCOSE LEVELS WERE NOT IN ACCEPTABLE RANGE. THE SENSOR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456323 FINISHED GOODS MATERIAL MASTER 1001 ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED MMT-7020

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR