BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 17508244 · Received August 11, 2023

    Report

    Report Number
    2032227-2023-253506
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 23, 2023
    Report Date
    October 30, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000456634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP IMMEDIATELY ALARMED AN OPEN BOOK IMAGE ONCE INSTALLING AN AA BATTERY. UNABLE TO PERFORM DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE). TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO THE RESERVOIR COMPARTMENT. SUCCESSFULLY DOWNLOADED PUMP HISTORY FILES AND TRACES USING THUMP SOFTWARE. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) TRIGGERED BY THREE CONSECUTIVE PUMP ERROR 63 CRITICAL HANDLING ALARMS FOUND IN THE ADAPT ERROR LOG TOOL NO TIME AND DATE WERE NOTED (FILE NUMBER: 690 2106, LINE NUMBER: 130 878, VARIABLE #: N/A) DUE TO A POSSIBLE HARDWARE FAILURE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, AND FORCE SENSOR. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: CORRODED BATTERY TUBE, CORRODED BATTERY TUBE SPRING, CRACKED CASE, SCRATCHED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), AND PILLOWING KEYPAD OVERLAY. UNABLE TO VERIFY CUSTOMER'S COMPLAINT FOR BLANK DISPLAY DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE). CRITICAL PUMP ERROR (OPEN BOOK IMAGE) WAS CONFIRMED DURING TESTING DUE TO THREE CONSECUTIVE PUMP ERROR 63 ALARMS. PUMP ERROR 63 WAS CONFIRMED DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. EXPOSED TO MOISTURE WAS CONFIRMED FOUND ON THE ELECTRONIC ASSEMBLY, MOTOR, FORCE SENSOR, AND BATTERY TUBE. 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 HAS REPORTED THE PUMP IS NOT TURNING ON AND THE WATER IS ON THE SCREEN. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE AND THE PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085468 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 HG5UYE2ZZ 000000763000456634

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Unknown