BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 12373651 · Received August 26, 2021

    Report

    Report Number
    2032227-2021-185448
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 17, 2021
    Report Date
    April 28, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED POSSIBLE UNDER DELIVERY ANOMALY FOUND ON 08/17/2021. DEVICE PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT ACCURACY TEST, AND SELF TEST. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. NO UNDER DELIVERY ANOMALIES NOTED DURING TESTING. UNIT SUCCESSFULLY DOWNLOADED TO THUS AND CARELINK. CONFIRMED DELIVERIES OF 0.075U BOLUS ON AUG 17, 2021 AT 00:38, 0.15U BOLUS ON AUG 17, 2021 AT 01:05, 0.125U BOLUS ON AUG 17, 2021 AT 01:57, 0.025U BOLUS ON AUG 17, 2021 AT 04:54, 0.3U BOLUS ON AUG 17, 2021 AT 11:33, 0.15U BOLUS ON AUG 17, 2021 AT 12:37, AND 0.19U BOLUS ON AUG 17, 2021 AT 14:49. SEVERAL BOLUS'S WERE PROGRAMMED, DELIVERED AND RECORDED PROPERLY IN THE PUMP HISTORY. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY. IN SUMMARY, INSULIN PUMP PASSED REQUIRED TESTING. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY WAS 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. 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THE INSULIN PUMP WAS UNDER DELIVERING INSULIN. CUSTOMER DID NOT GET ENOUGH INSULIN, INSULIN PUMP DID NOT RECEIVE ANY INSULIN FLOW BLOCK ALARM. 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
    1273046 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG542GP 000000763000317140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown