BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 18872506 · Received March 11, 2024

    Report

    Report Number
    2032227-2024-139315
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    February 24, 2024
    Report Date
    December 11, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT, AND SELF TEST. UNIT WAS SUCCESSFULLY DOWNLOADED USING THUMP SOFTWARE. ON ADAPT, PUMP ERROR 15 WAS RECORDED ON (B)(6) 2024 20:30:08.000 DUE TO HARDWARE ERROR (FILE # = 38, LINE # = 442). PUMP ERROR 23 WAS RECORDED ON (B)(6) 2024 20:33:02.000. PUMP ERROR 4 WAS RECORDED ON (B)(6) 2024 20:30:08.000. THE POWER MANAGEMENT PARAMETERS GRAPH CONFIRMED THE UNLOADED VOLTAGE (UNLOADED VLITH) AND LOADED VOLTAGE (LOADED VLITH) ARE WITHIN SPEC RANGE. HOWEVER, FAILED BATT TEST (58) WAS RECORDED ON (B)(6) 2024 20:30:11.000. PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION AND FOUND NO MOISTURE OR PHYSICAL DAMAGE. TEST P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. THE FOLLOWING DAMAGES WERE RECORDED: PILLOWING KEYPAD OVERLAY AND SCRATCHED CASE IN SUMMARY, CUSTOMER CONCERN FOR PUMP ERROR 15 CONFIRMED DUE TO HARDWARE ERROR. ISOLATE TO ELECTRONIC STACK. PUMP ERROR 4 CONFIRMED IN DOWNLOAD HISTORY REVIEW. PUMP ERROR 23 AND FAILED BATT TEST NOT CONFIRMED, HOWEVER BOTH NOTED IN DOWNLOAD HISTORY REVIEW. 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, 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 RECEIVED A PUMP ERROR 4 (THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM), PUMP ERROR 15 ( THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO), BATTERY FAILED AND PUMP ERROR 23 (POST-RESET RAM CRC ALARM). THE CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT THE ALARMS RECURRED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS NOT PERFORMED AND IT WAS UNKNOWN WHETHER THE CUSTOMER WOULD CONTINUE THE USE OF THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944405 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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown