BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 19881242 · Received August 1, 2024

    Report

    Report Number
    2032227-2024-213766
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    April 25, 2024
    Report Date
    August 1, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INSIDE THE UNITED STATES. UNIT PASSED SELF-TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. LOW RESERVOIR ALARM WAS SET TO 20 UNITS, AND IT ALARMED AT 13 UNITS AND FUNCTIONED PROPERLY. NO UNEXPECTED ALARMS AND ALERT NOTED DURING TESTING. UNIT WAS SUCCESSFULLY DOWNLOAD USING THUMP FOR HISTORY FILES AND TRACE FILES. LOW RESERVOIR ALERT WAS NOT FOUND IN HISTORY FILE AND TRACES. PUMP ERROR 63 VARIABLE (15) WAS FOUND ON 04/25/20224 12:43 IN HISTORY FILES. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿EVIDENCE OF MOISTURE DAMAGE¿ON THE FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED BATTERY TUBE, BATTERY TUBE THREADS CRACKED, CRACKED CASE, SCRATCHED CASE, CRACKED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), PILLOWING KEYPAD OVERLAY, SERIAL NUMBER LABEL MISSING. NO UNEXPECTED ALARMS OR ALERTS WERE NOTED DURING TESTING. LOW RESERVOIR ANOMALY IS NOT CONFIRMED. PUMP ERROR 63 IS CONFIRMED DUE TO BEING FOUND IN HISTORY FILE AND DUE TO HARDWARE ANOMALY. 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 LOW RESERVOIR ANOMALY. THE CUSTOMER REPORTED, NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-1886. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT RETURN WAS REQUESTED FOR MMT-1886. AND THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164712 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown