BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17196602 · Received June 26, 2023

    Report

    Report Number
    2032227-2023-224463
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    May 29, 2023
    Report Date
    August 9, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST AND DISPLACEMENT TEST. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUMP. NO PUMP ERROR 63 ALARMS WERE NOTED DURING TESTING. A REVIEW OF THE PUMP HISTORY FILE REVEALS THAT THE PUMP EXPERIENCED SIX (6) PUMP ERROR 63 ALARMS DUE TO A PROBLEM WITH THE TWI INTERFACE OR WITH AD5161 CHIP, (LISTED BELOW): (B)(6)2023 12:17:40 HARDWAREERRORALARM (63) LINENUMBER: 147 FILENUMBER: 2017 VARIABLEINFO: 15 (B)(6)202317:55:05 HARDWAREERRORALARM (63) LINENUMBER: 147 FILENUMBER: 2017 VARIABLEINFO: 15 (B)(6)2023 20:49:37 HARDWAREERRORALARM (63) LINENUMBER: 147 FILENUMBER: 2017 VARIABLEINFO: 15 (B)(6)202310:14:19 HARDWAREERRORALARM (63) LINENUMBER: 147 FILENUMBER: 2017 VARIABLEINFO: 15 (B)(6)202307:08:26 HARDWAREERRORALARM (63) LINENUMBER: 147 FILENUMBER: 2017 VARIABLEINFO: 15 (B)(6)202312:23:57 HARDWAREERRORALARM (63) LINENUMBER: 147 FILENUMBER: 2017 VARIABLEINFO: 15 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, CRACKED SELECT BUTTON KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED BATTERY COMPARTMENT, AND PILLOWING KEYPAD OVERLAY. PUMP ERROR 63 ALARMS ARE CONFIRMED, FAULT ISOLATED TO THE HARDWARE. 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. 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 GOT A "PUMP ERROR 63 ALARM" NOTIFICATION; PUMP ERROR 63 WAS REMEDIED BY CLEARING THE ALERT BY REWINDING THE PUMP. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221788 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 HG59JWXZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female