BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 12767738 · Received November 8, 2021

    Report

    Report Number
    2032227-2021-214764
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 30, 2021
    Report Date
    May 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SOFTWARE VERSION 6.5V. RETAINER RING BLACK. CUSTOMER RETURNED DEVICE FOR AN ALLEGED PUMP ERROR 38 ALARM AND PUMP ERROR 23 ALARM FOUND ON (B)(6) 2021. DEVICE PASSED THE SELF TEST. UNABLE TO PERFORM THE DISPLACEMENT TEST, PRIME OR SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST DUE TO A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST. DEVICE MONITORED WITHOUT THE TEST ENERGIZER BATTERY INSIDE THE BATTERY COMPARTMENT AND REINSERTS IT BACK INTO THE BATTERY COMPARTMENT FOR LESS THAN 10 MINUTES AND NO UNEXPECTED PUMP ERROR 23 ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND A CORRODED MOTOR HOME SWITCH. CORROSION WAS ALSO FOUND ON THE ELECTRONIC ASSEMBLY, FORCE SENSOR AND VIBRATOR ASSEMBLY NOTED. PUMP ERROR 38 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON (B)(6)2021 15:51:18.000, (B)(6)/2021 15:55:16.000, (B)(6)2021 16:05:58.000, (B)(6)/2021 16:08:20.000, (B)(6)2021 16:19:42.000, (B)(6)/2021 16:29:00.000, (B)(6)/2021 16:31:25.000, (B)(6)/2021 16:36:47.000, (B)(6)2021 16:45:50.000 AND (B)(6)2021. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON (B)(6)/2021 16:03:12.000. A TEST MOTOR WAS USED AND CONTINUED TESTING. DEVICE REWIND, LOAD RESERVOIR AND NO RESERVOIR DETECTED ALARMS PROPERLY. DEVICE REWINDS SUCCESSFULLY. DEVICE PASSED THE REWIND TEST. IN CONCLUSION, THE DEVICE HAD A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST WAS 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 CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. PUMP ERROR 23 ALARM WAS NOT CONFIRMED. PUMP ERROR 38 ALARM WAS CONFIRMED. DEVICE ERROR 38 ALARM WAS DUE TO A CORRODED MOTOR HOME SWITCH. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON THE ELECTRONIC ASSEMBLY, FORCE SENSOR AND VIBRATOR ASSEMBLY NOTED. 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 ALARMED MULTIPLE ERROR. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE NOT ABLE TO REWIND THE INSULIN PUMP. 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
    1663184 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 HG55Z4J 000000763000384258

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown