BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 20794828 · Received November 27, 2024

    Report

    Report Number
    2032227-2024-276266
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 3, 2024
    Report Date
    January 31, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000264727
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND ON: 11/02/2024 16:07:22.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/03/2024 15:41:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/03/2024 15:42:58.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/03/2024 15:44:56.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING PRIME. 11/03/2024 15:55:48.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. 11/03/2024 18:01:44.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNEXPECTED NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM NOTED. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 03-NOV-2024 IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS FOUND ON: 11/03/2024 18:29:54.000 POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. DURING VISUAL INSPECTION, CORROSION WAS FOUND ON THE BATTERY TUBE ASSEMBLY NOTED. THE PUMP WAS CUT OPEN AND FOUND CORROSION ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOT CONFIRMED. HOWEVER, DURING VISUAL INSPECTION CORROSION WAS FOUND ON THE BATTERY TUBE ASSEMBLY, PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. 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

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED, DUE TO REGIONAL PRIVACY REGULATIONS. 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. 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 AN INSULIN FLOW BLOCKED ALARM. THE CUSTOMER REPORTED, NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1782K. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-1782K WAS REQUESTED. AND CUSTOMER RESPONSE WAS, THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452747 PUMP MMT-1782K 670G V4.11 MM AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG5L8PR 000000763000264727

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown