BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1712KL 640G V4.10 BK SF MG

    MDR report key: 13566018 · Received February 20, 2022

    Report

    Report Number
    2032227-2022-115778
    Event Type
    Malfunction
    Date Received
    February 20, 2022
    Date of Event
    July 29, 2021
    Report Date
    February 20, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED NO DELIVERY ALARM ON (B)(6) 2021. THE UNIT P-CAP / TEST RESERVOIR LOCKS IN PLACE PROPERLY. DAMAGED/CRACKED RETAINER RING DURING VISUAL INSPECTION NOTED. THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND SELF TEST. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO UNEXPECTED OCCLUSIONS OR DELIVERY ANOMALY, BOLUS ANOMALY OR BASAL ANOMALY NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. ¿NO DELIVERY (7) ALARM WAS FOUND IN HISTORY FILE DURING NORMAL BOLUS ON (B)(6) 2021 00:25:41.000. (B)(6) 2021 00:01:15.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED = 1 BOLUSAMOUNTDELIVERED = 1, (B)(6) 2021 00:25:41.000 NORMALBOLUSDELIVERED- NORMALBOLUSAMOUNTPROGRAMMED = 1 BOLUSAMOUNTDELIVERED = 0.35, (B)(6) 2021 00:26:00.000 ALARMALERTNOTIFICATION-NO DELIVERY (7) (B)(6) 2021 03:10:14.000 NORMALBOLUSDELIVERED-NORMALBOLUSAMOUNTPROGRAMMED = 0.5 BOLUSAMOUNTDELIVERED = 0.5 IN SUMMARY, CUSTOMER ALLEGED NO DELIVERY ALARM NOT CONFIRMED. (B)(4). THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.. 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 INSULIN PUMP ALARMED INSULIN FLOW BLOCK. THE CUSTOMER STATED THAT THE INSULIN NOT EXITED TUBING. THE CUSTOMER WAS ADVISED TO REWIND INSULIN PUMP, REINSERT RESERVOIR AND LOAD RESERVOIR TO AT LEAST 5.0 UNIT BUT INSULIN PUMP AGAIN ALARMED INSULIN FLOW BLOCK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619563 PUMP MMT-1712KL 640G V4.10 BK SF MG PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712KL 000000763000317195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown