BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 20793975 · Received November 27, 2024

    Report

    Report Number
    2032227-2024-275912
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 2, 2024
    Report Date
    January 27, 2025
    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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT RECEIVED PUMP ERROR 130 ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM THE DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TESTS OR VERIFY CRITICAL PUMP ERROR (OPEN BOOK IMAGE) DUE TO THE PUMP ERROR 130. THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. IN FURTHER FULL REVIEW IN THE PUMP HISTORY FOUND MULTIPLE 130 ALARMS ON 11/02/2024 22:07:27, 11/02/2024 22:08:36, 11/02/2024 22:25:52.000 AND PUMP ERROR 43 ALARM ON 11/02/2024 22:15:58, 11/02/2024 22:16:58, 11/02/2024 22:25:48, 11/02/2024 22:29:10.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ELECTRONIC ASSEMBLY DURING VISUAL INSPECTION. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: UNIT HAD SCRATCHED CASE, STAINED KEYPAD OVERLAY, CRACKED BATTERY TUBE THREADS, CRACKED CASE (BATTERY TUBE). UNABLE TO CONFIRM CRITICAL PUMP ERROR (OPEN BOOK IMAGE) DUE TO PUMP ERROR 130. PUMP ERROR 130 DURING REWIND AND PUMP ERROR 130, 43 ALARMS IN THE PUMP HISTORY CONFIRMED DUE TO CORRODED MOTOR HOME SWITCH. 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 CRITICAL PUMP ERROR (OPEN BOOK IMAGE). THE CUSTOMER REPORTED, NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1886. TROUBLESHOOTING WAS PERFORMED. AND EXPLAINED, THE INSULIN PUMP PERFORMED SAFETY CHECKS. AND THE ERROR WAS FOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP. MMT-1886 WAS REQUESTED. AND CUSTOMER RESPONSE WAS, THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849558 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 HG6EGYWZZ 000000763000521554

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown