BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 18805519 · Received February 29, 2024

    Report

    Report Number
    2032227-2024-133974
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    February 14, 2024
    Report Date
    March 26, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AFTER BATTERY INSTALLATION. UNABLE TO PERFORM THE SELF TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, AND ACTIVE CURRENT MEASUREMENT TEST DUE TO THE CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. A REVIEW OF THE PUMP HISTORY FILE REVEALS NO FATAL ALARMS OR CRITICAL ERROR HANDLING ALARMS THAT WOULD TRIGGER A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. THE MAIN ERROR LOG AND PUMP DETAILED TRACE REVEAL THERE WERE TEN (10) INSTANCES OF PUMP ERROR 63 ALARMS DUE TO RF CHIP ERRORS AND ONE (1) INSTANCE OF A PUMP ERROR 4 ALARM (A CONSEQUENCE OF ERROR 63), LISTED BELOW: 1X PUMP ERROR 63 (LINENUMBER 5591 FILENUMBER 632) 2/12/2024 09:33 1X PUMP ERROR 63 (LINENUMBER 5591 FILENUMBER 632) 2/12/2024 14:22 1X PUMP ERROR 63 (LINENUMBER 5591 FILENUMBER 632) 2/12/2024 14:23 1X PUMP ERROR 63 (LINENUMBER 5591 FILENUMBER 632) 2/12/2024 14:31 1X PUMP ERROR 63 (LINENUMBER 466 FILENUMBER 642) 2/12/2024 14:32 1X PUMP ERROR 4 (LINENUMBER 2690 FILENUMBER 32122) 2/12/2024 14:32 1X PUMP ERROR 63 (LINENUMBER 496 FILENUMBER 643) 2/12/2024 14:36 1X PUMP ERROR 63 (LINENUMBER 5591 FILENUMBER 632) 2/13/2024 10:40 1X PUMP ERROR 63 (LINENUMBER 5591 FILENUMBER 632) 2/14/2024 09:46 1X PUMP ERROR 63 (LINENUMBER 5591 FILENUMBER 632) 2/14/2024 09:54 1X PUMP ERROR 63 (LINENUMBER 466 FILENUMBER 642) 2/14/2024 09:54 ON 2/14/2024 AT 09:54 CONSECUTIVE CRITICAL ERROR HANDLING ALARMS (ERROR 63) WERE GENERATED AND ON THE THIRD INSTANCE, CAUSED THE CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) AND PUMP ERROR 63 ALARMS, PUMP ERROR 4 ALARM, AND CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM ARE ALL CONFIRMED, FAULTS ARE ISOLATED TO THE HARDWARE. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER HAD A CRITICAL PUMP ERROR (OPEN BOOK IMAGE). TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926420 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 NG3389852H

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male