BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 14641954 · Received June 9, 2022

    Report

    Report Number
    2032227-2022-207182
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    June 4, 2022
    Report Date
    January 16, 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

    (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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT. RETAINER RING = BLACK. CASE TYPE = NGP . CUSTOMER RETURNED PUMP FOR AN ALLEGED LOW BGS, BLANK DISPLAY AND CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM FOUND ON 04-JUN-2022. AS PER THE CUSTOMER'S NOTE, THE CUSTOMER WILL GO TO THE NEAR HOSPITAL TO GET INSULIN. PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. NO BLANK DISPLAY NOTED. UNABLE TO PERFORM THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. UNABLE TO UPLOAD PUMP TO CARELINK DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM TRIGGERED BY MULTIPLE CONSECUTIVE PUMP ERROR 63 ALARMS ON 06/04/2022 17:31:01.000, 06/04/2022 17:52:24.000, 06/04/2022 18:04:24.000, 06/04/2022 18:46:04.000 AND 06/04/2022 18:49:00.000 RECORDED IN THE FORMATTED HISTORY FILE/DETAIL TRACE FILE. AS PER GLOBAL LOGIC ANALYSIS (ESF#: 3926945), PUMP ERROR 63 ALARMS (TWI) (LINE NUMBER 147 FILE NUMBER 2017), SUSPECTED ON HW. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. HOWEVER, CORROSION WAS FOUND ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE MOTOR AND VIBRATOR ASSEMBLY NOTED. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BGS. BLANK DISPLAY WAS NOT CONFIRMED. UNABLE TO PERFORM THE REQUIRED TESTING AND UPLOAD PUMP TO CARELINK DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO MULTIPLE CONSECUTIVE PUMP ERROR 63 ALARMS. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 63 ALARMS WERE DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON T. 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. THE INFORMATION RELATED TO OCCUPATION HAS BEEN UPDATED AND PROVIDED IN E3 SECTION AND G2 SECTION ALSO UPDATED OF THIS REPORT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED CRITICAL PUMP ERROR WITH OPEN BOOK IMAGE AND INSULIN PUMP WAS NOT WORKING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS SUCCESSFULLY PERFORMED HOWEVER THE CUSTOMER WILL DISCONTINUE THE USE OF DEVICE.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195466 MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1881 HG5UYE0ZZ 000000763000456634

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown