BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 20030673 · Received August 22, 2024

    Report

    Report Number
    2032227-2024-223552
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 27, 2024
    Report Date
    October 24, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAPTURED INTO B5 AND H6 (HEALTH EFFECT - CLINICAL CODE AND HEALTH EFFECT - IMPACT CODE) WHICH WAS NOT IN THE INITIAL REPORT BEING SUBMITTED VIA THIS FOLLOW UP REPORT. 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

    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. 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

    THE CUSTOMER REPORTED THAT THEY WENT TO THE EMERGENCY ROOM (ER) ON (B)(6) 2024 AT 9:00AM DUE TO HYPOGLYCEMIA. BLOOD GLUCOSE AT TIME OF EVENT WAS 42 MG/DL. USER WAS TREATED AT THE ER WITH ORANGE JUICE AND DEXTROSE. WHEN ASKED WHAT LED TO THE EVENT, THE USER STATED SG V BG DIFFERENCE, SG WAS READING 67 MG/DL AND BG WAS READING 42 MG/DL, WHICH CAUSED THEN TO HAVE A HYPOGLYCEMIC SEIZURE. THE CUSTOMER ALLEGED THAT THE GRAND MAL SEIZURE CAUSED THEM TO HIT THEIR HEAD DUE TO LOW BLOOD GLUCOSE. CUSTOMER STATED THEY HAD COVID A WEEK PRIOR TO EVENT. MEDICATION USER WAS ON INCLUDED ACETAMINOPHEN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE DUE TO SENSOR GLUCOSE VS. BLOOD GLUCOSE. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 42 MG/DL. THE CUSTOMER REPORTED HYPOGLYCEMIA, WHICH WAS TREATED WITH GLUCOSE/CARB INTAKE, EMS/AMBULANCE/ER VISIT, MANUAL INJECTION/INSULIN PEN, OTHERS. THE EVENT INVOLVED PRODUCTS MMT-332A, MMT-1884L, MMT-7040A, AND MMT-441A. TROUBLESHOOTING WAS PERFORMED, AND THE ISSUE WAS NOT RESOLVED. THE CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED LOW BLOOD GLUCOSE EVENT, AND THE CUSTOMER WAS USED THE AUTO MODE FEATURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. THE CUSTOMER WILL CONTINUE USING THE DEVICE, AND NO PRODUCT RETURN IS REQUIRED FOR MMT-1884L. PRODUCT RETURN REQUESTED FOR MMT-7040A. CUSTOMER DECLINED TO RETURN OR IS UNABLE TO RETURN. NO PRODUCT RETURN IS REQUIRED FOR MMT-441A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117689 PUMP MMT-1884L MM780G BLE 3.0 MG/ML AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884L NG3421288H

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention FRN-MMT-332A-RSVR, UNOMED INF SET, OZP-MMT-7040A-S