BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 21837905 · Received April 15, 2025

    Report

    Report Number
    2032227-2025-154405
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    October 17, 2024
    Report Date
    June 23, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED SELF-TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT ACCURACY TEST AND DISPLACEMENT TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUMP AND CARELINK. NO ALARMS OR ALERT NOTED DURING TESTING. THE ELECTRONIC ASSEMBLIES WERE INSPECTED, AND NO ANOMALIES NOTED. HOWEVER, MOISTURE DAMAGE NOTED TO MOTOR ASSEMBLIES DURING VISUAL INSPECTION. THE P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CORRODED BATTERY TUBE, CORRODED MOTOR HOME SWITCH. PLEASE SEE BELOW FOR THE FIRST TEN BOLUSES LISTED ON THE EVENT DATE 17-OCT-2024 IN THE PUMP HISTORY FILE. 10/17/2024 03:51:24.000 NORMALBOLUSDELIVERED (220). SYSTEMTIME = 10/17/2024 03:51:24.000. BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). BOLUSAMOUNTDELIVERED: 4000 (0.4 U) . 10/17/2024 04:36:40.000 NORMALBOLUSDELIVERED (220). SYSTEMTIME = 10/17/2024 04:36:40.000. BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). BOLUSAMOUNTDELIVERED: 4000 (0.4 U) . 10/17/2024 07:29:58.000 NORMALBOLUSDELIVERED (220). SYSTEMTIME = 10/17/2024 07:29:58.000. BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). BOLUSAMOUNTDELIVERED: 20000 (2 U) . 10/17/2024 08:19:30.000 NORMALBOLUSDELIVERED (220). SYSTEMTIME = 10/17/2024 08:19:30.000. BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). BOLUSAMOUNTDELIVERED: 2000 (0.2 U) . 10/17/2024 09:02:32.000 NORMALBOLUSDELIVERED (220). SYSTEMTIME = 10/17/2024 09:02:32.000. BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). BOLUSAMOUNTDELIVERED: 5000 (0.5 U) . 10/17/2024 09:46:55.000 NORMALBOLUSDELIVERED (220). SYSTEMTIME = 10/17/2024 09:46:55.000. BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). BOLUSAMOUNTDELIVERED: 2000 (0.2 U) . 10/17/2024 10:19:44.000 NORMALBOLUSDELIVERED (220). SYSTEMTIME = 10/17/2024 10:19:44.000. BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). BOLUSAMOUNTDELIVERED: 5000 (0.5 U). 10/17/2024 10:35:11.000 NORMALBOLUSDELIVERED (220). SYSTEMTIME = 10/17/2024 10:35:11.000. BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). BOLUSAMOUNTDELIVERED: 30000 (3 U) . 10/17/2024 14:08:48.000 NORMALBOLUSDELIVERED (220). SYSTEMTIME = 10/17/2024 14:08:48.000. BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). BOLUSAMOUNTDELIVERED: 30000 (3 U). 12/12/2024 16:41:01.000 NORMALBOLUSDELIVERED (220). SYSTEMTIME = 12/12/2024 16:41:01.000. BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0). BOLUSAMOUNTDELIVERED: 30000 (3 U). PUMP PASSED FUNCTIONAL TESTING AND NO ALARMS OR ALERTS NOTED DURING TESTING. POSSIBLE OVER DELIVERY ANOMALY WAS NOT CONFIRMED. 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. 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 INSIDE THE UNITED STATES. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 INSULIN PUMP WAS OVER DELIVERING THE INSULIN. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1882. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1882 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116246 MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1882 NG3439896H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown