BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NGP

    MDR report key: 16829533 · Received April 28, 2023

    Report

    Report Number
    2032227-2023-198891
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    August 1, 2022
    Report Date
    May 30, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    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. INFORMATION HAS BEEN CORRECTED WHICH WAS NOT CORRECT IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B1,B2,B5,D10,H1,H6( HECC,HEIC) WITH THIS REPORT.

    Additional Manufacturer Narrative · 0

    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. 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.

    Description of Event or Problem · 0

    UPDATED SUMMARY: MEDTRONIC LEGAL RECEIVED INFORMATION FROM THE ATTORNEY OF THE FAMILY ON APRIL 25, 2023, MEDTRONIC RECEIVED NOTICE OF A DEVICE/PRODUCT LEGAL HOLD NOTIFICATION CONTAINING 410 INDIVIDUAL CLAIMANTS.

    Description of Event or Problem · 0

    MEDTRONIC LEGAL RECEIVED INFORMATION FROM THE ATTORNEY OF THE FAMILY ON APRIL 12, 2023, MEDTRONIC RECEIVED NOTICE OF A DEVICE/PRODUCT LEGAL HOLD NOTIFICATION CONTAINING 510 INDIVIDUAL CLAIMANTS. THE REPORTER ALLEGES THAT THE USE OF ONE OR MORE MEDTRONIC MINI MED 600 SERIES INSULIN PUMPS WITH A DAMAGED, MISSING, OR BROKEN RETAINER RING CAUSED THE CLAIMANT TO SUFFER PERSONAL INJURIES AND WAS HOSPITALIZED FOR 3-7 DAYS. THE ALLEGATION DID NOT SPECIFY THE PUMP IDENTIFIER (SERIAL NUMBER) AND THEREFORE ALL 600 SERIES INSULIN PUMPS IN POSSESSION OF THE CLAIMANT, INCLUDING THIS PUMP, ARE CONSIDERED POTENTIALLY WITHIN THE SCOPE OF THE REPORT PENDING CONFIRMATION OF THE AFFECTED SERIAL NUMBER(S). ALL RELATED REPORTS WILL BE UPDATED ACCORDINGLY WHEN AND IF THE AFFECTED SERIAL NUMBER WAS IDENTIFIED. IT WAS UNKNOWN WHETHER THE CUSTOMER HAD USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT AND WHETHER THE SMARTGUARD AUTO MODE OF THE INSULIN PUMP WAS USED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE THE USE OF THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335841 UNKNOWN NGP AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC MINIMED UNK_NGP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention| H FRN-MMT-332A-RSVR, UNOMED INF SET| FRN-MMT-332A-RSVR, UNOMED INF SET