BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8806265 · Received July 19, 2019

    Report

    Report Number
    2032227-2019-32529
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    April 30, 2019
    Report Date
    July 19, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 424 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE LEVEL WAS 393 MG/DL AND OTHER BLOOD GLUCOSE LEVEL WAS 250 MG/DL AND 90 MG/DL. CUSTOMER PERFORMED TROUBLESHOOTING FOR HYPERGLYCEMIA. THE CUSTOMER WAS TREATED WITH BOLUS FOR HIGH BLOOD GLUCOSE. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTS THEY DID CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER STATED INSULIN DID EXIT AT THE QUICK RELEASE. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS ON AUTO MODE AT THE TIME OF INCIDENT. CUSTOMER WISHES TO CHECK THEIR SETTINGS. EXPLAIN AUTO MODE WAS CONSERVATIVE AND DELIBERATE IN HOW IT BRINGS GLUCOSE BACK TOWARD THE TARGET OF 120 MG/DL WHICH HELPS MINIMIZE LOW GLUCOSE AND THIS MEANS THERE WILL BE TIMES WHEN SENSOR GLUCOSE WILL BE HIGHER THAN EXPECTED. CUSTOMER WAS ADVISED TO CONTACT HEALTH CARE PROFESSIONAL AND CLARIFY WHY THIS NUMBERS WERE NOT PROGRAM WITH THE INSULIN PUMP AS IT MAY BE REASON WHY AUTO MODE WAS NOT WORKING EFFICIENTLY WHICH MAY CAUSE HIGH BLOOD SUGAR. CUSTOMER¿S HIGH BLOOD GLUCOSE LEVEL WAS RULED OUT THAT INSULIN PUMP PROGRAMMING WAS THE ALLEGED REASON. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601047 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG30LE1 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other UNOMED SET