BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 12907123 · Received December 1, 2021

    Report

    Report Number
    2032227-2021-224894
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 19, 2021
    Report Date
    April 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER = BLACK. THE CUSTOMER ALLEGED THE PUMP IS UNDER DELIVERING CAUSING HIGH BGS ON 11/19/2021. 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 .08680 INCHES. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. NO UNDER DELIVERY ANOMALY NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO DAMAGE 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 PHYSICAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE PUMP PASSED ALL FUNCTIONAL TESTING. HIGH BG AND UNDER DELIVERY ANOMALY ARE NOT CONFIRMED. THE FORMATTED HISTORY FILE LIST THE FOLLOWING MANUAL PROGRAMMED BOLUS DELIVERIES FOR 11/19/2021: 11/19/2021 07:15 NORMALBOLUSAMOUNTPROGRAMMED = 2 BOLUSAMOUNTDELIVERED = 2. 11/19/2021 13:01 NORMALBOLUSAMOUNTPROGRAMMED = 1.9 BOLUSAMOUNTDELIVERED = 1.9. 11/19/2021 19:18 NORMALBOLUSAMOUNTPROGRAMMED = 1.3 BOLUSAMOUNTDELIVERED = 1.3. 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 · 0

    (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. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER ALLEGED THE INSULIN PUMP WAS UNDER DELIVERING. CURRENT BLOOD GLUCOSE OF CUSTOMER WAS 225 MG/DL. CUSTOMER EXPERIENCED HYPERGLYCEMIA. CUSTOMER WAS NOT USING AUTO MODE. CUSTOMER PERFORMED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER FAILED TO SUCCESSFULLY COMPLETE ALL STEPS IN DISPLACEMENT VERIFICATION TABLE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809972 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG3YC7Q 000000763000316631

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female