BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 17359259 · Received July 20, 2023

    Report

    Report Number
    2032227-2023-239454
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 29, 2023
    Report Date
    December 5, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000456634
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    S/W VERSION 5.2B. RETAINER RING= BLACK. CASE TYPE =NGP. CUSTOMER RETURN PUMP DUE TO ALLEGED FAILED BATTERY TEST AND COSMETIC DAMAGE LOCATED AT THE BELT CLIP RAILS AND HIGH BGS IT WAS FOUND ON 29 JUNE 2023. UNIT PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, ACTIVE CURRENT TEST, SLEEP CURRENT TEST, AND SELF-TEST. NO FAILED BATTERY ALARM NOTED DURING TESTING. NO ALARMS, ALERT, AND ANOMALIES NOTED DURING TESTING. PUMP WAS DOWNLOADED USING THUMP FOR HISTORY FILES AND TRACES. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH), AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. FAILED BATTERY TEST OCCURRED ON 06/27/2023 22:17--22:19 IN HISTORY FILES AND TRACES. PUMP ERROR 53 WAS FOUND ON (FILE#43574 LINE#39510 06/27/2023 22:17) AND (FILE#99 LINE#114 06/27/2023 22:23) IN HISTORY FILES AND TRACES. THIS WAS EXPECTED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF MOISTURE DAMAGE ON THE ELECTRONIC STACK AND FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED BATTERY TUBE, SCRATCHED CASE, CRACKED CASE, BATTERY TUBE THREADS CRACKED, STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED CASE CORNER OF BELT CLIP RAILS, CRACKED CASE (BATTERY TUBE), SERIAL NUMBER LABEL MISSING. P-CAP WAS ATTACHED AND LOCKED INTO PLACE PROPERLY. FAIL BATTERY TEST IS NOT CONFIRMED. PUMP ERROR 53 IS CONFIRMED DUE TO HARDWARE ANOMALY. COSMETIC DAMAGE IS CONFIRMED AT THE BELT CLIP RAILS. UNABLE TO CONFIRM HIGH BGS DURING TESTING. 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 · 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. 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. 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 REPORTED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 22.5 MMOL/L AND RECEIVED A SOFTWARE ERROR DETECTED (PUMP ERROR 53), BATTERY FAILED ALARM, AND REPORTED DAMAGE TO THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER WAS TREATED WITH AN INSULIN PUMP. IT WAS FOUND THAT THERE WAS A CRACK WHERE THE BATTERY CAP RUN THROUGH THE BELT CLIP AND THE GOES DOWN AT THE BOTTOM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WAS ADVISED TO REVERT TO THE BACKUP PLAN AS PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766052 MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1881 HG5J8RHZZ 000000763000456634

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown