BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 18199580 · Received November 23, 2023

    Report

    Report Number
    2032227-2023-308338
    Event Type
    Malfunction
    Date Received
    November 23, 2023
    Date of Event
    November 4, 2023
    Report Date
    January 9, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE PUMP BECAUSE THE END USER IS EXPERIENCING HIGH BGS DUE TO THE INSULIN FLOW BLOCKED ALERTS OCCURRING DURING BOLUS DELIVERY FOUND ON (B)(6) 2023. THE PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT TEST AT .08715 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONED PROPERLY DURING THE BASIC OCCLUSION, OCCLUSION, AND FORCE SENSOR TESTS. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS WERE NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUS. A REVIEW OF THE PUMP HISTORY FILE REVEALS THERE ARE A TOTAL OF (B)(4) NO DELIVERY (INSULIN FLOW BLOCKED) ALARMS DURING NOVEMBER 2023, DETAILS ARE LISTED BELOW: (B)(6) 2023 12:38:22 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BOLUS WIZARD DELIVERY. (B)(6) 2023 12:57:50 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BOLUS WIZARD DELIVERY. (B)(6) 2023 13:21:00 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BASAL DELIVERY. (B)(6) 2023 09:41:54 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BOLUS WIZARD DELIVERY. (B)(6) 2023 09:59:14 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BOLUS WIZARD DELIVERY. (B)(6) 11/07/2023 10:27:00 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BASAL DELIVERY. (B)(6) 2023 10:29:08 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BOLUS WIZARD DELIVERY. (B)(6) 2023 10:30:08 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NOD ELIVERY (7) DURING A BOLUS WIZARD DELIVERY. (B)(6) 2023 10:40:12 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BOLUS WIZARD DELIVERY. (B)(6) 2023 10:40:52 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING A BOLUS WIZARD DELIVERY. THE PUMP WAS CUT OPEN FOR VISUAL INSPECTION. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE, CRACKED BATTERY COMPARTMENT AT THE CORNER OF THE BELT CLIP RAILS, AND PILLOWING KEYPAD OVERLAY. INSULIN FLOW BLOCKED ALARM COMPLAINT IS NOT CONFIRMED. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. THE PUMP HISTORY FILE LISTS SIX (6) BOLUSES ON THE EVENT DATE, 11/4/2023, LISTED BELOW: (B)(6) 2023 10:35:14.000 NORMAL BOLUS DELIVERED BOLUS PROGRAMMING METHOD = BOLUS WIZARD NORMAL BOLUS AMOUNT PROGRAMMED = 2.6 BOLUS AMOUNT DELIVERED = 2.6. (B)(6) 2023 12:36:08.000 NORMAL BOLUS DELIVERED BOLUS PROGRAMMING METHOD = BOLUS WIZARD NORMAL BOLUS AMOUNT PROGRAMMED = 3.4 BOLUS AMOUNT DELIVERED = 3.4. (B)(6) 2023 14:57:54.000 NORMAL BOLUS DELIVERED BOLUS PROGRAMMING METHOD = BOLUS WIZARD NORMAL BOLUS AMOUNT PROGRAMMED = 0.5 BOLUS AMOUNT DELIVERED = 0.5. (B)(6) 2023 14:58:41.000 NORMAL BOLUS DELIVERED BOLUS PROGRAMMING METHOD = BOLUS WIZARD NORMAL BOLUS AMOUNT PROGRAMMED = 0.7 BOLUSAMOUNTDELIVERED = 0.7. (B)(6) 2023 20:10:38.000 NORMAL BOLUS DELIVERED BOLUS PROGRAMMING METHOD = BOLUS WIZARD NORMAL BOLUS AMOUNT PROGRAMMED = 3.7 BOLUS AMOUNT DELIVERED = 3.7. (B)(6) 2023 23:07:24.000 NORMAL BOLUS DELIVERED BOLUS PROGRAMMING METHOD = BOLUS WIZARD NORMAL BOLUS AMOUNT PROGRAMMED = 0.7 BOLUS AMOUNT DELIVERED = 0.7. PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE, 11/4/2023: (B)(6) 2023, (B)(4) DAILYTOTALS. DAILY TOTAL COLLECTION START TIME = (B)(6) 2023 (B)(4). DAILY TOTAL OF ALL INSULIN DELIVERED = (B)(4). DAILY TOTAL OF BASAL INSULIN DELIVERED = (B)(4). DAILY TOTAL OF BOLUS INSULIN DELIVERED = (B)(4). THERE WERE NO AUTO SUSPEND EVENTS ON THE EVENT DATE, 11/4/2023. THERE WERE NO USER SUSPEND EVENTS ON THE EVENT DATE, 11/4/2023. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED AN INSULIN FLOW BLOCK ALARM DURING BOLUS DELIVERY. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN FLOW BLOCK WAS RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL CONTINUE THE USE OF THE PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498694 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL NG3171575H 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female