BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 7606476 · Received June 15, 2018

    Report

    Report Number
    2032227-2018-06011
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    April 25, 2018
    Report Date
    June 15, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED DIFFERENT BLOOD GLUCOSE LEVELS OF, 150, 180, 190, 50, 40, 300, 400, 225, 200, 263, 152,170, 191, 162, 250,MG/DL. CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVEL WAS 40 MG/DL AND HIGH BLOOD GLUCOSE LEVEL WAS 400 MG/DL. CUSTOMER HAD NO ANY SYMPTOMS. CUSTOMER WAS LOW BLOOD GLUCOSE LEVEL TREATED WITH GLUCOSE SHOTS AND BOLUS FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT INSULIN PUMP COULD DETECT OCCLUSION .TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449793 RESERVOIR 3ML MMT-332A PUMP, INFUSION FRN MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other