BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 18835009 · Received March 5, 2024

    Report

    Report Number
    2032227-2024-136441
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 18, 2024
    Report Date
    May 27, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521547
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    P-CAP LOCKED PROPERLY DURING TESTING. UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT, AND SELF TEST. THE ADAPT TOOL ALSO RECORDED PUMP ERROR 23 ON (B)(6) 2024 11:28:37.000, 68 ON (B)(6) 2024 11:17:16.000 AND (B)(6) 2024 11:27:00.000, AND 49 ON (B)(6) 2024 11:17:16.000 AND (B)(6) 2024 11:28:13.000. PER SOFTWARE ENGINEERING LOG PUMP ERROR 68, 49, AND 23 WERE GENERATED ON THE PUMP STARTUP DUE TO THE MEMORY CORRUPTION. ISOLATE TO ELECTRONIC ASSEMBLIES. PROCEEDED BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION ON CONNECTORS AND ELECTRONIC ASSEMBLY. ALL CONNECTORS WERE PLUGGED IN PROPERLY HOWEVER, DURING DECONSTRUCTIVE ANALYSIS MOISTURE DAMAGE WAS NOTED ON VIBRATOR HARDNESS BOARD CAUSING AN INTERMITTENT ELECTRICAL SHORT. UNIT WAS RECEIVED WITH KEYPAD OVERLAY PEELING, SERIAL NUMBER LABEL DAMAGE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, AND PILLOWING KEYPAD OVERLAY. IN SUMMARY, CUSTOMER CONCERN OF BLANK DISPLAY WAS NOT CONFIRMED DUE TO UNIT POWERING ON PROPERLY. UNEXPECTED BATTERY POWER LOSS WAS NOT CONFIRMED DUE TO NO POWER ANOMALIES DURING TESTING. CONCERN OF PUMP ERROR 49, PUMP ERROR 23, AND PUMP ERROR 68 WERE CONFIRMED IN PUMP DOWNLOAD HISTORY. PUMP ERROR 2 WAS NOT EVIDENT IN HISTORY. 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. 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. 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 MULTIPLE ALARMS NAMELY TRACE POINTERS ARE INVALID (PUMP ERROR 68), POST-RESET RAM CRC ALARM (PUMP ERROR 23), HISTORY POINTERS ARE CORRUPTED (PUMP ERROR 49) AND POWER LOSS ALARM AND BLANK DISPLAY ALONG WITH HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER HAD EXPERIENCED HIGH BLOOD GLUCOSE EVENT VALUE 33 MMOL. THE CUSTOMER IS NOT CURRENTLY REPORTING SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE EVENT AND WAS TREATED WITH INSULIN PUMP . THE PUMP ERROR WAS OCCURRED DURING THE BASAL. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM SUCCESSFULLY AND STATED THAT THE PUMP REWIND WAS COMPLETED . THE PUMP WAS IN USE WITHIN 48 HRS OF THE HIGH BLOOD GLUCOSE EVENT REPORTED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE TO USE THE DEVICE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165523 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 HG5VC0YZZ 000000763000521547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown