BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 20832745 · Received December 3, 2024

    Report

    Report Number
    2032227-2024-278971
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 18, 2024
    Report Date
    January 22, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P150001
    Removal / Correction Number
    2032227-060322-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO CONFIRM BATTERY CAP CONTACT MISSING/DAMAGED DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. THE PUMP WAS RECEIVED WITH A PARTIALLY BROKEN BATTERY TUBE THREADS AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP PASSED THE SELF TEST AND ACTIVE CURRENT MEASUREMENT. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. THE PUMP WAS MONITORED FOR SEVERAL HOURS WITH A NEW TEST AA 1.5V BATTERY TO ENABLE THE PUMP TO CHARGE. A BATTERY SIMULATOR WAS USED AND CONTINUED TESTING. STILL, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. 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. INSERT BATTERY ALARM WAS FOUND ON: 11/13/2024 21:21:52.000, 11/13/2024 21:23:36.000 11/13/2024 21:24:44.000, 11/13/2024 21:34:00.000 11/18/2024 09:01:04.000, 11/18/2024 09:05:38.000 11/18/2024 09:06:32.000, 11/18/2024 09:16:00.000 11/18/2024 09:17:30.000 LOW BATTERY ALERT WAS FOUND ON: 11/13/2024 21:18:00.000 POWER LOSS ALARM WAS FOUND ON: 11/13/2024 21:37:04.000 PUMP ERROR 23 ALARM WAS FOUND ON: 11/18/2024 09:17:03.000 INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT WAS EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER. THE CUSTOMER HAD USED A LOW POWER BATTERY. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. IN FURTHER CHECKING OF THE PUMP HISTORY RECORDS: BATTERY CYCLE 77.0 RECEIVED THE LOWBATTERYALERT (104) ON 11/13/2024 21:18:00 AFTER MORE THAN 7 DAYS AT 23.19 DAYS. BATTERY CYCLE 74.0 RECEIVED THE LOWBATTERYALERT (104) ON 09/19/2024 08:50:00 AFTER MORE THAN 7 DAYS AT 13.7 DAYS. BATTERY CYCLE 72.0 RECEIVED THE LOWBATTERYALERT (104) ON 08/17/2024 10:11:01 AFTER MORE THAN 7 DAYS AT 21.62 DAYS. WITH REFERENCE TO THE BATTERY DURATION FAILURE ANALYSIS INSTRUCTIONS, CUSTOMER DID NOT EXPERIENCE AN UNEXPECTED POWER LOSS OF LESS THAN 7 DAYS PER THE PUMP HISTORY RECORDS. THERE WERE NO OTHER UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 18-NOV-2024 IN THE FORMATTED HISTORY FILE. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. A HIGH SLEEP CURRENT MEASUREMENT WAS CONFIRMED DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. NO RETAINER RING DAMAGE NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER AND A SCRATCHED CASE. RETAINER RING DAMAGE WAS NOT CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED AT THE BATTERY COMPARTMENT OF THE PUMP DURING ANALYSIS. UNABLE TO CONFIRM BATTERY CAP CONTACT MISSING/DAMAGED DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. BATTERY CAP CONTACT MISSING/DAMAGED WAS UNKNOWN. CUSTOMER ALLEGED FOR UNEXPECTED BATTERY POWER LOSS WAS NOT CONFIRMED. HOWEVER, A HIGH SLEEP CURRENT MEASUREMENT WAS CONFIRMED DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. 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. 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 DAMAGE (PHYSICAL OR COSMETIC), RETAINER RING DAMAGE, BATTERY CAP CONTACT MISSING/DAMAGED, UNEXPECTED BATTERY POWER LOSS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1880. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1880 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297218 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 HG5CSBSZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female