BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 8503524 · Received April 11, 2019

    Report

    Report Number
    3004209178-2019-80218
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    March 31, 2019
    Report Date
    April 11, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169873834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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 HE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 439 MG/DL. THE CUSTOMER'S CURRENT BLOOD GLUCOSE VALUE WAS 290 MG/DL. THE CUSTOMER STATED THAT HIS AVERAGE BLOOD GLUCOSE LEVEL WAS 80-100 MG/DL; HOWEVER, RECENTLY IT HAD BEEN INCREASED TO 200-439 MG/DL. HE HAD CHANGED THE SET BUT THE ISSUE DIDN'T RESOLVE. THE CUSTOMER WAS NOT INSISTING ON INSULIN PUMP REPLACEMENT. HE DID NOT ALLEGE THAT THE INSULIN PUMP WAS UNDER DELIVERING. IT WAS REPORTED THAT THE CUSTOMER PERFORMED HIGH PRESSURE TEST AND RECEIVED AN ALARM AT 2 UNITS. HE WAS ADVISED TO CHANGE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT AS PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296570 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG24M65 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other UNK-RSVR, UNOMED UNK