BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 18786904 · Received February 27, 2024

    Report

    Report Number
    2032227-2024-132925
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 10, 2024
    Report Date
    March 26, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE 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. PUMP ERROR 38 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/10/2024 08:48:52.000, 02/10/2024 08:51:33.000, 02/10/2024 08:52:49.000, 02/10/2024 08:54:05.000 02/10/2024 09:02:57.000, 02/10/2024 09:04:20.000, 02/10/2024 09:10:42.000, 02/10/2024 09:22:13.000 02/10/2024 09:24:08.000, 02/10/2024 09:25:18.000, 02/10/2024 09:27:59.000 02/10/2024 08:33:13.000, 02/10/2024 08:45:44.000, 02/10/2024 09:12:37.000, 02/10/2024 09:18:33.000, 03/12/2024 13:47:00:000. NO PUMP ERROR 37, 39, 41, 42, 43, 79, 80, 82 AND 130 ALARM ON THE FORMATTED HISTORY FILE NOTED. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND A JAMMED MOTOR GEAR BOX. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. A TEST MOTOR WAS USED AND CONTINUED REWIND TEST. THE PUMP PASSED THE REWIND TEST AND NO CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST. A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST WAS CONFIRMED DUE TO A JAMMED MOTOR GEAR BOX. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 2 DAYS PRIOR TO THE EVENT DATE 10-FEB-2024 IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/10/2024 08:49:18.000, 02/10/2024 08:49:46.000, 02/10/2024 08:52:09.000, 02/10/2024 09:15:03.000, 02/10/2024 09:15:31.000, 02/10/2024 09:18:42.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/10/2024 08:49:18.000, 02/10/2024 08:49:27.000. 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 ALARMS/ALERTS WERE NOTED. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER MAY HAVE USED A NO POWER/DEPLETED BATTERY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY AND A SCRATCHED CASE. A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST WAS CONFIRMED DUE TO A JAMMED MOTOR GEAR BOX. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 RECEIVED A PUMP ERROR 38 ALARM-¿NO MOTOR MOVEMENT OR NEGLIGIBLE MOVEMENT. RETRIES TO FREE A STUCK MOTOR FAILED.¿ TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM SUCCESSFULLY AND THE PUMP REWIND WAS UNCOMPLETED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND IT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102751 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 NG3362322H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male