BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13440894 · Received February 3, 2022

    Report

    Report Number
    2032227-2022-108943
    Event Type
    Injury
    Date Received
    February 3, 2022
    Date of Event
    January 28, 2022
    Report Date
    March 22, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000367046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK CUSTOMER RETURNED PUMP FOR AN ALLEGED COSMETIC DAMAGE LOCATED AT THE BACK, POSSIBLE UNDER DELIVERY AND WAS HOSPITALIZED FOR HIGH BGS FOUND ON (B)(6)2022. PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP 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 DAT AT 0.08730 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF (B)(4)2022, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND FOUND BOLUS WIZARD DELIVERY OF DAILYTOTALOFBOLUSINSULINDELIVERED = 72.3 U BOLUS. (B)(6)2022 01:30:52.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 2.2 BOLUSAMOUNTDELIVERED = 2.2 (B)(6)2022 04:52:00.000 DUALBOLUSPARTDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 2.5 SQUAREBOLUSAMOUNTPROGRAMMED = 6.5 BOLUSAMOUNTDELIVERED = 6.5 (B)(6)2022 08:39:34.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 4.6 BOLUSAMOUNTDELIVERED = 4.6 (B)(6)2022 15:23:30.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 10.5 BOLUSAMOUNTDELIVERED = 10.5 (B)(6)2022 16:39:26.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 7.5 BOLUSAMOUNTDELIVERED = 7.5 (B)(6)2022 18:36:56.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 6 BOLUSAMOUNTDELIVERED = 6 (B)(6)2022 19:39:54.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 6 BOLUSAMOUNTDELIVERED = 6 (B)(6)2022 20:33:14.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 7.5 BOLUSAMOUNTDELIVERED = 5.4 (B)(6)2022 21:17:37.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 15 BOLUSAMOUNTDELIVERED = 10.25 (B)(6)2022 21:23:48.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 9 BOLUSAMOUNTDELIVERED = 9 (B)(6)2022 21:39:32.000 NORMALBOLUSDELIVERED NORMALBOLUSAMOUNTPROGRAMMED = 4.5 BOLUSAMOUNTDELIVERED = 4.5 THE PUMP 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 BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED DURING TESTING. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A SCRATCHED CASE AND A SERIAL NUMBER LABEL FADING. COSMETIC DAMAGE WAS CONFIRMED AT THE BACK OF THE PUMP. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. 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 · 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. 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 · 0

    INFORMATION RECEIVED BY MEDTRONIC STATED THAT THE CUSTOMER ALLEGED UNDER DELIVERY OF INSULIN. CUSTOMER EXPERIENCED A HYPERGLYCEMIA. CUSTOMER BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 678 MG/DL AND HIS CURRENT BLOOD GLUCOSE LEVEL WAS 140 MG/DL. CUSTOMER WAS PERFORMED A HIGH PRESSURE TEST BUT IT WAS FAILED. CUSTOMER WAS USED INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. NO HARM WAS REQUIRED DURING MEDICAL INTERVENTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749613 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 HG54FLH 000000763000367046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other