BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 8622300 · Received May 18, 2019

    Report

    Report Number
    2032227-2019-04240
    Event Type
    Malfunction
    Date Received
    May 18, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 18, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE CHEAP PLASTIC WAS BROKE AND THE RESERVOIR COMPARTMENT ALSO BROKE. CUSTOMER'S BLOOD GLUCOSE VALUE UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415817 TIME REVEL INSULIN INFUSION PUMP INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR