BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 11911309 · Received June 1, 2021

    Report

    Report Number
    2032227-2021-151346
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    March 29, 2019
    Report Date
    September 24, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    Removal / Correction Number
    Z-0955-2020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0955-2020 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 Manufacturer Narrative · 0

    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. SERIAL AND LOT NUMBER WERE ADDED IN SECTION D4 AS IT WAS NOT PROVIDED IN THE INITIAL REPORT. SECTIONS B1 AND B2 WERE ALSO CORRECTED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE PATIENT WEIGHT CHANGE FROM 0 TO 146 WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. SO, THE CORRECT PATIENT WEIGHT AS PER NEW ADDITIONAL INFORMATION IS 146 WHICH IS UPDATED IN SECTION A4. ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE INCIDENT DATE CHANGE WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. SO, THE CORRECT INCIDENT DATE HAS BEEN CHANGED FROM 01-MAR-2019 TO 29-MAR-2019 AS PER NEW ADDITIONAL INFORMATION AND WHICH IS UPDATED SECTION B3. ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE AWARENESS DATE AND NOTIFY DATE CHANGE WHICH WAS NOT INCLUDED IN THE INITIAL REPORT. SO, THE CORRECT AWARENESS DATE AND NOTIFY DATE HAS BEEN CHANGED TO 27-MAY-2021 AS PER NEW ADDITIONAL INFORMATION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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

    MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING DEFECTIVE INSULIN PUMP FROM THE ATTORNEY OF THE FAMILY. THE INFORMATION RECEIVED ON (B)(6) 2021 STATED INSULIN PUMP FAILED IN ITS DELIVERY OF INSULIN TO HER, RESULTING IN AN ACUTE EPISODE OF DIABETIC KETOACIDOSIS AND SEVERE HYPOGLYCEMIA, THE CUSTOMER WAS USING MINIMED 670 INSULIN PUMP. THE INSULIN PUMP WILL BE AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813104 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG3QW91

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Hospitalization