BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 20830753 · Received December 3, 2024

    Report

    Report Number
    2032227-2024-278832
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 7, 2024
    Report Date
    March 24, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300063923501
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED DISPLACEMENT TEST AND SELF TEST. UNIT WAS PROGRAMMED WITH TEST TRANSMITTER LINK (LINK 3 GL3). THE PUMP WAS CONNECTED TO A TEST TRANSMITTER AND MONITORED WITHOUT ANY CONNECTION INTERRUPTIONS. NO TRANSMITTER ANOMALIES WERE NOTED. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR DURING COMPLAIN CALL THAT MIGHT OF TRIGGER THE REASON COMPLAIN. UNIT WAS SUCCESSFULLY DOWNLOADED USING THUMP SOFTWARE. DURING DOWNLOAD REVIEW USING THE PUMP DETAILED TRACE IT RECORDED PUMP ERROR 53. PUMP ERROR 53 (LINE = 1216 AND FILE NUMBER =709) WAS TRIGGERED SEVERAL TIMES ON (B)(6) 2024 FROM 18:16:22.000 TO (B)(6) 2024 16:39:28.000. PER ENGINEERING TROUBLESHOOTING GUIDE, IT WAS DETERMINED THAT PUMP ERROR 53 (FILENUM/LINENUM =709/1216) WAS TRIGGERED SINCE THE HANDLE FOR GST DEVICE WAS NOT FOUND. IT IS A KNOWN SW ISSUE ESF 4784573. PROCEEDED BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC ASSEMBLIES. PER VISUAL INSPECTION NO MOISTURE DAMAGE AND ALL CONNECTORS WERE PLUGGED IN PROPERLY DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED CASE. IN CONCLUSION, CUSTOMER CONCERN FOR PUMP ERROR 53 WAS NOT CONFIRMED DURING TESTING, HOWEVER, PUMP ERROR 53 WAS IN THE HISTORY/TRACE FILES ON (B)(6) 2024 DUE TO SOFTWARE ISSUE. NO COMMUNICATION BETWEEN PUMP AND TRANSMITTER WAS NOT CONFIRMED. UNIT AND TRANSMITTER COMMUNICATED PROPERLY DURING TESTING. 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 PUMP ERROR 53(SOFTWARE ERROR DETECTED). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1886. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ABLE TO CLEAR THE ERROR BUT WAS UNABLE TO COMPLETE THE REWIND PROCESS NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1886 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297103 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 NG3778821H 000076300063923501

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Unknown