BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12670231 · Received October 21, 2021

    Report

    Report Number
    2032227-2021-207708
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 13, 2021
    Report Date
    March 31, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED PUMP ERROR 38 ALARM AND KEYPAD ANOMALY FOUND ON (B)(6) 2021. PUMP PASSED THE SELF TEST. UNABLE TO PERFORM THE DISPLACEMENT TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST DUE TO A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. ALL BUTTONS FUNCTION PROPERLY. THE KEYPAD OVERLAY WAS REMOVED TO PERFORM VISUAL INSPECTION AND NO DAMAGE IN THE KEYPAD ASSEMBLY NOTED. PUMP PASSED THE KEYPAD VOLTAGE TEST. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND A CORRODED MOTOR HOME SWITCH. CORROSION WAS ALSO FOUND ON THE ELECTRONIC ASSEMBLY. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR AND VIBRATOR ASSEMBLY NOTED. THE J1 CONNECTOR ON PCBA 1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. PUMP ERROR 38 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON (B)(6) 2021 19:54:28.000, (B)(6) 2021 19:54:59.000, (B)(6) 2021 19:55:28.000, (B)(6) 2021 19:56:04.000, (B)(6) 2021 19:56:53.000, (B)(6) 2021 19:57:40.000 AND (B)(6) 2021 20:04:47.000 FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.1 MV). A TEST MOTOR WAS USED AND CONTINUED TESTING. THE PUMP REWIND, LOAD RESERVOIR AND NO RESERVOIR DETECTED ALARMS PROPERLY. THE PUMP REWINDS SUCCESSFULLY. THE PUMP PASSED THE REWIND TEST. IN CONCLUSION, THE PUMP HAD A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST DUE TO A CORRODED MOTOR HOME SWITCH. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. KEYPAD ANOMALY WAS NOT CONFIRMED. PUMP ERROR 38 ALARM WAS CONFIRMED. PUMP ERROR 38 ALARM DUE TO A CORRODED MOTOR HOME SWITCH. CORROSION WAS ALSO FOUND ON THE ELECTRONIC ASSEMBLY. 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

    (B)(4). 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A NO MOTOR MOVEMENT OR NEGLIGIBLE MOVEMENT ALARM. CUSTOMER WERE NOT ABLE TO SUCCESSFULLY CLEAR ALARM. INSULIN PUMP ERROR ALARMED WHEN CUSTOMER WAS TRYING TO REWIND INSULIN PUMP AND UNABLE TO PERFORM DISPLACEMENT TEST. THERE WAS NO RESPONSE FROM BUTTONS. BLOCK MODE WAS NOT ACTIVE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576241 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG4ST8NZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male