BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 7649280 · Received June 29, 2018

    Report

    Report Number
    3004209178-2018-86349
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    May 30, 2018
    Report Date
    August 23, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169873834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED IN THE SECTION OF CONCOMITANT PRODUCT WITH THE INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN INCLUDED WITH THIS REPORT.

    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 HIGH BLOOD GLUCOSE AND INSULIN PUMP ALARMED FOR NO DELIVERY. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 525 MG/DL AT THE TIME OF INCIDENT AND 310 MG/DL AT THE TIME OF CALL. OTHER BLOOD GLUCOSE LEVEL WERE 151, 250, 310 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE LEVEL. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492339 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG28Q4N 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other