BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 19284932 · Received May 10, 2024

    Report

    Report Number
    2032227-2024-167542
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 26, 2024
    Report Date
    September 13, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000734435
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, AND DISPLACEMENT TEST. THE INSULIN FLOW BLOCKED ALARM FUNCTIONED PROPERLY DURING THE BASIC OCCLUSION, OCCLUSION, AND FORCE SENSOR TESTS. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. THE TRACE AND HISTORY FILES WERE SUCCESSFULLY DOWNLOADED USING THUMP. A REVIEW OF THE PUMP HISTORY FILE REVEALS THE FOLLOWING NO DELIVERY (INSULIN FLOW BLOCKED) ALARMS LISTED BELOW: A REVIEW OF THE PUMP HISTORY FILE REVEALS ON (B)(6) 2024 THERE WERE SIX (6) NO DELIVERY (INSULIN FLOW BLOCKED) ALARMS, LISTED BELOW: (B)(6) 2024 06:11:00 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BASAL DELIVERY. (B)(6) 2024 06:13:00 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BASAL DELIVERY. (B)(6) 2024 06:15:00 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BASAL DELIVERY. (B)(6) 2024 06:16:00 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BASAL DELIVERY. (B)(6) 2024 06:21:14 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A CANNULA FILL DELIVERY. (B)(6) 2024 06:25:42 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A CANNULA FILL DELIVERY. THE PUMP WAS CUT OPEN FOR VISUAL INSPECTION. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2) AND MOTOR ASSEMBLY. A SC1 CAP LOCKS INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING A PHYSICAL INSPECTION: SCRATCHED CASE, CRACKED DOWN ARROW BUTTON KEYPAD OVERLAY, AND MINOR SCRATCHED LCD WINDOW. MINOR SCRATCHED LCD WINDOW IS CONFIRMED. INSULIN FLOW BLOCKED ALARM COMPLAINT IS NOT CONFIRMED. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. 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 SCRATCHES TO THE LCD SCREEN AND DIFFICULT TO READ THE SCREEN. CUSTOMER WAS ALSO RECEIVED INSULIN FLOW BLOCK ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS INITIATED FOR INSULIN FLOW BLOCK ALARM, CUSTOMER WAS REPORTING PAST EVET AND THE ISSUE WAS RESOLVED. TROUBLESHOOTING WAS PERFORMED FOR COSMETIC DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN STATUS FOR MMT-1885 IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2127357 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 NG3686700H 000000763000734435

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown