BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 20392396 · Received October 7, 2024

    Report

    Report Number
    2032227-2024-249653
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 16, 2024
    Report Date
    December 9, 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

    UNIT PASSED ALL FOLLOWING TESTS: DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, AND SELF TEST. NO UNEXPECTED INSULIN FLOW BLOCK ALARMS NOTED DURING TESTING. UNIT WAS SUCCESSFULLY DOWNLOADED USING THUMP SOFTWARE. HOWEVER ON ADAPT, CONFIRMED NO DELIVERY (7) ALARM ON 09/16/2024 14:05:35.000, 09/16/2024 14:07:00.000, 09/16/2024 14:07:32.000, AND 09/16/2024 14:11:07.000 ALL DURING BOLUS. PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION AND FOUND NO MOISTURE OR PHYSICAL DAMAGE. P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. THE FOLLOWING COSMETIC DAMAGES WERE NOTED: CRACKED KEYPAD OVERLAY AND SCRATCHED CASE. IN SUMMARY, CUSTOMER CONCERN FOR NO DELIVERY/OCCLUSION ALARM IS NOT CONFIRMED. UNIT FUNCTIONED PROPERLY AND PASSED ALL TESTING WITHIN SPEC. NO ALARMS NOTED DURING TESTING, HOWEVER NO DELIVERY (7) NOTED IN DOWNLOAD HISTORY REVIEW ON EVENT DATE. 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. 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 INSULIN FLOW BLOCK ALARM. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1886. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER CONFIRMED INSULIN DID NOT EXIT DURING 5U FILL CANNULA OR PUMP ALARMED. CUSTOMER RE-ATTEMPTED LOAD RESERVOIR/FILL TUBING PROCESS AFTER A COMPLETE SET CHANGE AND INSULIN DID NOT EXIT OR PUMP ALARMED. 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
    213991 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 HG526V9ZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown