BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12597680 · Received October 8, 2021

    Report

    Report Number
    2032227-2021-202865
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    September 15, 2021
    Report Date
    February 28, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. ON (B)(6) 2021 THE CUSTOMER ALLEGED PUMP UNDER DELIVERING AND WAS HOSPITALIZED FOR HIGH BGS. UNIT PASSED THE FUNCTIONAL TEST, 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 0.0875 INCHES. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED. THERE WAS A RELATED SVN WITH AN EVENT DATE OF (B)(6) 2021. THERE WAS OVER 400 BOLUSES DELIVERED BETWEEN (B)(6) 2021 TO (B)(6) 2021. REVIEWED THE FIRST 10 BOLUSES ON EACH DAY. (B)(6) 2021 00:04:21.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.075. BOLUS AMOUNT DELIVERED = 0.075. (B)(6) 2021 00:09:18.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.05. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2021 00:14:19.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.075. BOLUS AMOUNT DELIVERED = 0.075. 09/14/2021 01:24:17.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.075. BOLUS AMOUNT DELIVERED = 0.075. (B)(6) 2021 01:29:15.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.075. BOLUS AMOUNT DELIVERED = 0.075, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). (B)(6) 2021 01:34:13.000 NORMAL BOLUS DELIVERED. NORMAL BOLUS AMOUNT PROGRAMMED = 0.025. BOLUS AMOUNT DELIVERED = 0.025. (B)(6) 2021 01:39:12.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.025. BOLUS AMOUNT DELIVERED = 0.025. (B)(6) 2021 01:44:27.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.075. BOLUS AMOUNT DELIVERED = 0.075. (B)(6) 2021 01:49:11.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.075. BOLUS AMOUNT DELIVERED = 0.075. (B)(6) 2021 01:54:25.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.075. BOLUS AMOUNT DELIVERED = 0.075. (B)(6) 2021 00:00:00.000 DAILY TOTALS. EVENT TYPE = 63. SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). HISTORY RECORD LENGTH = 114. SYSTEM TIME = (B)(6) 2021 00:00:00.000. DAILY TOTAL COLLECTION START TIME = 09/14/2021 00:00:00.000. DURATION = 2160. NUMBER OF BG = 18. AVERAGE BG = 310. LOW BG = 157. HIGH BG = 397. BG MANUAL AND RECEIVED STANDARD DEVIATION = 64. DAILY TOTAL OF ALL INSULIN DELIVERED = 48.45. DAILY TOTAL OF BASAL INSULIN DELIVERED = 24.25. PERCENTAGE OF DAILY TOTAL DELIVERED AS BASAL INSULIN = 50. DAILY TOTAL OF BOLUS INSULIN DELIVERED = 24.2. (B)(6) 2021 00:04:14.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.05. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2021 00:09:11.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.025. BOLUS AMOUNT DELIVERED = 0.025. (B)(6) 2021 00:16:02.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.05. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2021 00:21:02.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.05. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2021 00:26:02.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.05. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2021 00:31:02.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.025. BOLUS AMOUNT DELIVERED = 0.025. (B)(6) 2021 00:36:02.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.05. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2021 00:46:02.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.05. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2021 00:51:02.000 NORMAL BOLUS DELIVERED. NORMAL BOLUS AMOUNT PROGRAMMED = 0.025. BOLUS AMOUNT DELIVERED = 0.025. (B)(6) 2021 00:56:02.000 NORMAL BOLUS DELIVERED, SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE). NORMAL BOLUS AMOUNT PROGRAMMED = 0.05. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2021 00:00:00.000 DAILY TOTALS. EVENT TYPE = 63. SOURCE ID = PUMP (NGP IS IN CLOSED LOOP ACTIVE STATE) HISTORY RECORD LENGTH = 114. SYSTEM TIME = (B)(6) 2021 00:00:00.000. DAILY TOTAL COLLECTION START TIME = 09/15/2021 00:00:00.000. DURATION = 1440. NUMBER OF BG = 2. AVERAGE BG = 346. LOW BG = 298. HIGH BG = 393. BG MANUAL AND RECEIVED STANDARD DEVIATION = 47. DAILY TOTAL OF ALL INSULIN DELIVERED = 28.525. DAILY TOTAL OF BASAL INSULIN DELIVERED = 21.025. PERCENTAGE OF DAILY TOTAL DELIVERED AS BASAL INSULIN = 74. DAILY TOTAL OF BOLUS INSULIN DELIVERED = 7.5. NO BOLUS ANOMALY NOTED. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. UNIT HAD SCRATCHED CASE AND A PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. IN SUMMARY, CUSTOMER ALLEGATION FOR PUMP UNDER DELIVERING NOT CONFIRMED DURING FULL FUNCTIONAL TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. (B)(4). 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). A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED AFTER EMERGENCY MEDICAL SERVICES WERE DISPATCHED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2021. BLOOD GLUCOSE AT THE TIME OF EVENT WAS UNKNOWN. CURRENT BLOOD GLUCOSE WAS 350 MG/DL. THE CUSTOMER DID EXPERIENCE SYMPTOMS SUCH AS NAUSEA AND VOMITING A RESULT OF HIGH BLOOD GLUCOSE. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER DID NOT USE AUTO MODE FEATURE AT THE TIME OF HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494778 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5LRFR 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other FRN-UNK-RSVR, UNOMED INF SET| FRN-UNK-RSVR, UNOMED INF SET