BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12493103 · Received September 18, 2021

    Report

    Report Number
    2032227-2021-194778
    Event Type
    Malfunction
    Date Received
    September 18, 2021
    Date of Event
    September 10, 2021
    Report Date
    April 1, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM, REWIND ANOMALY AND KEYPAD ANOMALY FOUND ON (B)(6) 2021. DEVICE PASSED THE FUNCTIONAL TESTS, 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 DELIVERY ACCURACY TEST AT 0.08690 INCHES. DEVICE 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 UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THERE WAS NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 08:09:45.000, (B)(6) 2021 08:17:58.000, (B)(6) 2021 08:18:36.000, (B)(6) 2021 08:45:26.000, (B)(6) 2021 08:45:51.000, (B)(6) 2021 01:11:08.000 DURING BOLUS DELIVERY. NO MOTOR RELATED ERRORS/ALARMS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. ALL BUTTONS FUNCTION PROPERLY. THE KEYPAD OVERLAY WAS REMOVED TO PERFORM VISUAL INSPECTION AND NO DAMAGE IN THE KEYPAD ASSEMBLY NOTED. DEVICE PASSED THE KEYPAD VOLTAGE TEST. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE J1 CONNECTOR ON PCBA 1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM, REWIND ANOMALY AND KEYPAD ANOMALY WERE NOT CONFIRMED. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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 · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS HAD TO BE PRESSED HARDER TO GET RESPONSE. CUSTOMER STATED THAT INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS AND REWIND WAS SLOWER OCCASIONALLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390506 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4D5KG 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female