BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 19699345 · Received July 9, 2024

    Report

    Report Number
    2032227-2024-199364
    Event Type
    Death
    Date Received
    July 9, 2024
    Date of Event
    August 29, 2022
    Report Date
    November 19, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000393786
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    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. 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. THIS IS 1 OF 2 MEDWATCH REPORTS REGARDING THIS EVENT. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED RETAINER RING DAMAGE. THE EVENT INVOLVED PRODUCT(S) MMT-1780KPK, MMT-332A, MMT-1780KPK, UNOMEDICAL. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-1780KPK. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR MMT-1780KPK. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL.

    Description of Event or Problem · 0

    MEDTRONIC LEGAL RECEIVED INFORMATION ON FEB 15, 2024. THE REPORTER ALLEGED 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 DEATH. 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, WERE CONSIDERED POTENTIALLY WITHIN THE SCOPE OF THE REPORT PENDING CONFIRMATION OF THE AFFECTED SERIAL NUMBER(S). WHEN AND IF THE AFFECTED SERIAL NUMBER WAS IDENTIFIED, ALL RELATED REPORTS WILL BE UPDATED ACCORDINGLY. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE USING THE DEVICE. THE INSULIN PUMP WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250913 PUMP MMT-1780KPK 670G PATHWAY BLACK MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG5822R 000000763000393786

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Death FRN-MMT-332A-RSVR, UNOMED INF SET