BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 7900946 · Received September 24, 2018

    Report

    Report Number
    2032227-2018-32197
    Event Type
    Injury
    Date Received
    September 24, 2018
    Date of Event
    September 5, 2018
    Report Date
    September 23, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169873834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCES HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 410 MG/DL. CUSTOMER ALSO HAD BLOOD GLUCOSE LEVEL OF 132, 357, 151, 352 AND OVER 350 MG/DL. THE CUSTOMER TREATED WITH THE INSULIN PEN. THE CUSTOMER DID EXPERIENCE THE SYMPTOMS SUCH AS THIRSTY. THE CUSTOMER DID NOT WISH TO CONTINUE TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743000 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG2FR6R 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other FRN RESUNOMED INFSET