BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 19178475 · Received April 25, 2024

    Report

    Report Number
    2032227-2024-158257
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    April 4, 2024
    Report Date
    May 24, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000586195
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORRODED PCBA 1, PCBA 2 AND FORCE SENSOR. MOISTURE DAMAGE WAS FOUND ON THE MOTOR. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS TRIGGERED BY A PUMP ERROR 35 FATAL ALARM CONFIRMED IN THE HISTORY FILE ON 04/04/2024 23:17:00.000 AND ON 04/04/2024 23:27:00.000. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, AND PILLOWING KEYPAD OVERLAY. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 04-APR-2024 IN THE PUMP HISTORY FILE. (B)(6) 2024 07:33:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOWBATTERYALERT (104) (B)(6) 2024 08:17:52.000 BATTERYREMOVED (55) (B)(6) 2024 08:17:52.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2024 08:18:20.000 BATTERYINSERTED (44) (B)(6) 2024 23:17:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BROKENFORCESENSORERROR (35) (B)(6) 2024 23:20:19.000 BATTERYREMOVED (55) (B)(6) 2024 23:20:19.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2024 23:20:41.000 BATTERYINSERTED (44) (B)(6) 2024 23:20:54.000 BATTERYREMOVED (55) (B)(6) 2024 23:20:54.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2024 23:21:48.000 BATTERYINSERTED (44) (B)(6) 2024 23:22:23.000 BATTERYREMOVED (55) (B)(6) 2024 23:22:23.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2024 23:23:41.000 BATTERYINSERTED (44) (B)(6) 2024 23:27:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BROKENFORCESENSORERROR (35) 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. LOWBATTERYALERT (104) NOT CONFIRMED. PUMP ERROR 35 CONFIRMED IN THE PUMP HISTORY FILE. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO PUMP ERROR 35 ALARM. PUMP ERROR 35 ALARM CONFIRMED DUE TO CORRODED FORCE SENSOR. 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 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 A CRITICAL PUMP ERROR WITH AN OPEN BOOK IMAGE DISPLAYED ON THE PUMP SCREEN. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880L. TROUBLESHOOTING WAS PERFORMED FOR THE REPORTED EVENT. IT WAS STATED THAT THE CUSTOMER WAS SLEEPING WHEN THE ALARM OCCURRED. A PUMP ERROR 35(A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY) WAS DISPLAYED BEFORE THE OPEN BOOK IMAGE WAS DISPLAYED ON THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. A PRODUCT RETURN FOR MMT-1880L WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE PUMP WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860032 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG3181112H 000000763000586195

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female