BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 20235577 · Received September 17, 2024

    Report

    Report Number
    2032227-2024-239354
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 27, 2024
    Report Date
    December 2, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521554
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST AND THE ACTIVE CURRENT MEASUREMENT. THE PUMP HAD HIGH SLEEP CURRENT MEASUREMENT. PUMP FAILED THE SELF-TEST. THE PUMP ALARMED PUMP ERROR 75 DURING THE SELF-TEST. NO PUMP ERROR 23 NOTED DURING TESTING. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, BROKEN BELT CLIP RAIL AND PILLOWING KEYPAD OVERLAY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORRODED PCBA 1, MOISTURE DAMAGE ON THE PCBA2 AND MOISTURE DAMAGE ON THE MOTOR. NO DAMAGE NOTED ON THE FORCE SENSOR. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 27-AUG-2024 IN THE PUMP HISTORY FILE. 08/26/2024 22:14:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOWBATTERYALERT (104) 08/27/2024 00:17:51.000 BATTERYREMOVED (55) 08/27/2024 00:17:51.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) 08/27/2024 00:18:05.000 BATTERYINSERTED (44) 08/27/2024 00:56:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) 08/27/2024 13:19:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) 08/27/2024 15:01:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: TRACECHECKERROR (68) 08/27/2024 15:01:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: HISTORYPOINTERSBADALARM (49) 08/27/2024 15:01:30.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: HISTORYPOINTERSBADALARM (49) 08/27/2024 15:01:46.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) 08/27/2024 15:02:11.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: TRACECHECKERROR (68) 08/27/2024 15:02:11.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: HISTORYPOINTERSBADALARM (49) 08/27/2024 15:02:33.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: HISTORYPOINTERSBADALARM (49) 08/27/2024 15:02:45.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) 08/27/2024 17:51:30.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) 08/27/2024 18:01:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: POSTRESETRAMCRCALARM (23) THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK 3 TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY OR LOST SENSOR ALERT NOTED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. LOW BATTERY ALERT WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY IN THE PUMP IS LOW ON POWER. PUMP ERROR 23, PUMP ERROR 49, PUMP ERROR 68 AND PUMP ERROR 75 DURING THE SELF-TEST DUE TO CORRODED PCBA 1 AT J6 AND J7 CONNECTORS. LOWBATTERYALERT (104) - NOT CONFIRMED. LOSTSENSOR1ALERT (780) - NOT CONFIRMED. PUMP ERROR 49 - CONFIRMED IN THE PUMP HISTORY FILE. PUMP ERROR 49 CONFIRMED IN THE PUMP HISTORY FILE. PUMP ERROR 23 - CONFIRMED IN THE PUMP HISTORY FILE. PUMP ERROR 23, PUMP ERROR 49, PUMP ERROR 68 AND PUMP ERROR 75 DURING THE SELF-TEST DUE TO CORRODED PCBA 1 AT J6 AND J7 CONNECTORS AND MOISTURE DAMAGE ON PCBA 2. PUMP ERROR 23 CONFIRMED IN THE PUMP HISTORY FILE. PUMP ERROR 49 CONFIRMED IN THE PUMP HISTORY FILE. PUMP ERROR 68 CONFIRMED IN THE PUMP HISTORY FILE. PUMP ERROR 75 CONFIRMED DURING THE SELF-TEST. THE PUMP HAD HIGH SLEEP CURRENT MEASUREMENT DUE TO CORRODED PCBA 1 AND MOISTURE DAMAGE ON PCBA 2. 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 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED PUMP ERROR 23-POST-RESET RAM CRC ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1886. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ABLE TO CLEAR ERROR AND COMPLETE REWIND PROCESS. PUMP ERROR WASN'T IMMEDIATELY AFTER BATTERY CHANGE. INSTRUCTED THE CUSTOMER TO REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS AND PLACE THE PUMP IN STORAGE MODE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1886 WAS REQUESTED, AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531367 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 HG5VUTNZZ 000000763000521554

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Unknown