BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17495801 · Received August 10, 2023

    Report

    Report Number
    2032227-2023-252113
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    July 21, 2023
    Report Date
    October 11, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    S/W VERSION 5.2A. RETAINER RING = BLACK. CASE TYPE = NGP. CUSTOMER RETURNED PUMP FOR AN ALLEGED PUMP ERROR 43, PUMP ERROR 2 AND UNRESPONSIVE KEYPAD WERE FOUND ON 21-JUL-2023. PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST, SELF TEST AND DISPLACEMENT ACCURACY TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, MOTOR HOME SWITCH AND FORCE SENSOR. SUCCESSFULLY UTILIZED THUMP TO DOWNLOAD HISTORY FILES AND DETAIL TRACES. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED AND WAS TRIGGERED BY PUMP ERROR 40 FATAL ALARMS CONFIRMED IN THE HISTORY FILES ON 07/22/2023 10:01:00.000 DUE SOFTWARE ERROR (ESF#(B)(4) ; FILE NUMBER: 121; LINE NUMBER: 525) AND ON 07/22/2023 10:11:00.000 DUE TO A HARDWARE ERROR (ESF#(B)(4) ; FILE NUMBER: 26; LINE NUMBER: 1474). PUMP ERROR 2 ALARMED ON 07/21/2023 17:49:54.000 AND PUMP ERROR 3 ALARMED ON 07/21/2023 17:49:54.000 WERE FOUND IN THE HISTORY FILES. PUMP ERROR 53 ALARMED ON 07/21/2023 17:49:54.000 (FILE NUMBER: 32112; LINE NUMBER: 3901) FOUND IN THE HISTORY FILES. PUMP ERROR 43 ALARMED ON 07/21/2023 17:08:40.000 FOUND IN THE HISTORY FILES. PUMP ERROR 130 ALARM ON 07/21/2023 17:06:03.000 WAS FOUND IN THE HISTORY FILES. UNABLE TO DO THE MOTOR TEST DUE TO MOISTURE DAMAGE ON THE MOTOR ASSEMBLY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED BATTERY TUBE, BATTERY TUBE THREADS - CRACKED, CRACKED CASE, SCRATCHED CASE, KEYPAD OVERLAY PEELING, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, PILLOWING KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE AND LABEL DAMAGE (SERIAL NUMBER LABEL STAINED, FADED AND PEELING). CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO PUMP ERROR 40. PUMP ERROR 40 ALARM CONFIRMED DUE TO SOFTWARE ERROR AND HARDWARE ERROR. PUMP ERROR 2, PUMP ERROR 3, PUMP ERROR 43 AND PUMP ERROR 53 WERE CONFIRMED. UNABLE TO CONFIRM UNRESPONSIVE KEYPAD DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. 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. 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 PUMP ERROR 43 (AN ERROR IN THE MOTOR WAS DETECTED BY READING THE UNEXPECTED VALUE FROM HALL SENSOR) AND PUMP ERROR 2 (INTERPROCESSOR COMMUNICATION ERROR). THE CUSTOMER ALSO REPORTED KEYPAD ANOMALY. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER WAS UNABLE TO CLEAR THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE. THE PRODUCT WILL BE RETURNED FOR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892875 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 HG59PY1ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male