BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12224542 · Received July 26, 2021

    Report

    Report Number
    2032227-2021-172209
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    July 15, 2021
    Report Date
    October 3, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000090203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT.

    Description of Event or Problem · 0

    CUSTOMER'S PARENT REPORTED THAT THE CUSTOMER WAS HOSPITALIZED 3 TIMES WITHIN A PERIOD 3 WEEKS DUE HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. EMERGENCY MEDICAL SERVICES WERE DISPATCHED AND CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM AND ADMITTED TO THE HOSPITAL. THE FIRST ADVERSE EVENT HAPPENED AROUND (B)(6) 2021, NEXT ONE WAS ON (B)(6) 2021 AND ANOTHER ONE ON (B)(6) 2021. CUSTOMER'S PARENT WAS NOT ABLE TO PROVIDE THE BLOOD GLUCOSE VALUE AT THE TIME OF EACH INCIDENT. NO SYMPTOMS OF HIGH BLOOD GLUCOSE WERE MENTIONED. CUSTOMER DECLINED FURTHER TROUBLESHOOTING.

    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

    CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT CUSTOMER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021 DUE TO DIABETIC KETOACIDOSIS AND HYPERGLYCEMIA. CUSTOMER BLOOD GLUCOSE LEVEL WAS 420 MG/DL WHEN ADMITTED TO HOSPITAL. CUSTOMER STATED THAT THEY WERE FEELING SICK. CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN INFUSION IN THE HOSPITAL. CUSTOMER CURRENT BLOOD GLUCOSE LEVEL WAS 345 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS CURRENT OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THE AUTO MODE FEATURE WAS NOT ACTIVE AT THE TIME OF HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121366 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2E8AC 000000763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization FRN-UNK-RSVR, UNOMED SET| FRN-UNK-RSVR, UNOMED SET