BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12567750 · Received October 4, 2021

    Report

    Report Number
    2032227-2021-200685
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 30, 2021
    Report Date
    March 28, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000413750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK ON (B)(6) 2021 THE CUSTOMER ALLEGED INSULIN FLOW BLOCK ALARM AND HIGH BLOOD GLUCOSE. THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND SELF TEST. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS. PLEASE SEE BELOW FOR THE NO DELIVERY ALARM LISTED IN THE PUMP HISTORY FILE ON THE EVENT DATE. (B)(6) 2021 14:15:32.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS(B)(6) 2021 14:16:22.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 14:17:40.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)2021 14:18:17.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 14:24:15.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 14:28:42.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)2021 14:33:15.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 14:39:51.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/14:40:30.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BASAL (B)(6)/2021 14:40:54.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 15:30:33.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BASAL (B)(6)/2021 15:35:29.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BASAL (B)(6) 2021 16:30:19.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 16:37:43.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 17:03:20.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 17:04:09.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BASAL 09/30/2021 17:28:23.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING PRIME (B)(6)/2021 17:42:15.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 17:44:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING PRIME (B)(6)/2021 17:45:24.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING PRIME (B)(6)/2021 19:01:44.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 19:02:40.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING PRIME 09/30/2021 19:05:52.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING PRIME (B)(6)/2021 19:06:31.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 19:07:21.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 19:08:03.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 19:08:43.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BOLUS (B)(6)/2021 19:10:21.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BASAL (B)(6)/2021 19:15:25.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BASAL (B)(6) 2021 19:20:28.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BASAL (B)(6) 2021 19:25:28.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BASAL (B)(6)/2021 19:30:29.000 ALARM ALERT NOTIFICATION FAULT NUMBER: NO DELIVERY (7) - DURING BASAL THE CUSTOMER ALLEGED INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM IS NOT CONFIRMED. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. UNABLE TO CONFIRM ALLEGED HIGH BLOOD GLUCOSE. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN FLOW BLOCK ALARM RECURRING AFTER TROUBLESHOOTING. CUSTOMER STATED DISPLACEMENT TEST WAS PASS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464624 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG5FPSZ 000000763000413750

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male