BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 19030803 · Received April 3, 2024

    Report

    Report Number
    2032227-2024-150511
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    December 14, 2023
    Report Date
    April 3, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521547
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    003

    Narratives

    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. 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 OUTSIDE THE UNITED STATES. THE PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AFTER BATTERY INSTALLATION. 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. SUCCESSFULLY DOWNLOADED HISTORY AND TRACE FILES USING THUMP. A REVIEW OF THE PUMP HISTORY FILE REVEALS NO FATAL ALARMS OR CRITICAL ERROR HANDLING ALARMS THAT WOULD TRIGGER A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. THE MAIN ERROR LOG AND PUMP DETAILED TRACE FILES REVEAL ON 12/12/2023 THERE WERE FIVE (5) INSTANCES OF PUMP ERROR 63 ALARMS DUE TO HARDWARE ISSUES WITH THE LCD, LISTED BELOW: 1X PUMP ERROR 63 (LINENUMBER 19208 FILENUMBER 49) 12/12/2023 11:00 1X PUMP ERROR 63 (LINENUMBER 19208 FILENUMBER 49) 12/12/2023 11:07 1X PUMP ERROR 63 (LINENUMBER 2318 FILENUMBER 49) 12/12/2023 11:08 1X PUMP ERROR 63 (LINENUMBER 2318 FILENUMBER 49) 12/12/2023 11:08 1X PUMP ERROR 63 (LINENUMBER 707 FILENUMBER 2006) 12/12/2023 11:08 ON 12/12/2023 AT 11:08 CONSECUTIVE CRITICAL ERROR HANDLING ALARMS (ERROR 63) WERE GENERATED AND ON THE THIRD INSTANCE, CAUSED THE CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. THE PUMP WAS CUT OPEN FOR VISUAL INSPECTION. MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2) AND INSIDE THE BATTERY TUBE. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE, STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED BATTERY COMPARTMENT AT THE CORNER OF THE BELT CLIP RAILS, AND CRACKED BATTERY TUBE THREADS. COSMETIC DAMAGE ON THE BATTERY COMPARTMENT AND BATTERY TUBE THREADS IS CONFIRMED. CRITICAL PUMP ERROR (OPEN BOOK) ALARM AND PUMP ERROR 63 ALARM ARE CONFIRMED DUE TO MOISTURE DAMAGE ON THE HARDWARE. 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. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624230 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 NG3176115H 000000763000521547

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown