BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 15578266 · Received October 11, 2022

    Report

    Report Number
    2032227-2022-346903
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    September 23, 2022
    Report Date
    October 11, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 0.08695 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 23-SEP-2022, THERE WAS NO UNEXPECTED ALARMS/SUSPENDS NOTED AND FOUND BOLUS WIZARD DELIVERY OF DAILYTOTALOFBOLUSINSULINDELIVERED = 46.6 U. 09/23/2022 07:14:40.000; NORMALBOLUSDELIVERED. 09/23/2022 07:14:40.000: NORMALBOLUSAMOUNTPROGRAMMED = 4.6. 09/23/2022 07:14:40.000: BOLUSAMOUNTDELIVERED = 4.6. 09/23/2022 09:00:24.000; NORMALBOLUSDELIVERED. 09/23/2022 09:00:24.000; NORMALBOLUSAMOUNTPROGRAMMED = 6.4. 09/23/2022 09:00:24.000;BOLUSAMOUNTDELIVERED = 6.4. 09/23/2022 11:01:32.000; NORMALBOLUSDELIVERED. 09/23/2022 11:01:32.000; NORMALBOLUSAMOUNTPROGRAMMED = 7.5. 09/23/2022 11:01:32.000; BOLUSAMOUNTDELIVERED = 7.5. 09/23/2022 13:49:54.000; NORMALBOLUSDELIVERED. 09/23/2022 13:49:54.000; NORMALBOLUSAMOUNTPROGRAMMED = 3.5. 09/23/2022 13:49:54.000; BOLUSAMOUNTDELIVERED = 3.5. 09/23/2022 14:59:10.000; NORMALBOLUSDELIVERED. 09/23/2022 14:59:10.000; NORMALBOLUSAMOUNTPROGRAMMED = 6.5. 09/23/2022 14:59:10.000; BOLUSAMOUNTDELIVERED = 6.5. 09/23/2022 15:30:38.000; NORMALBOLUSDELIVERED. 09/23/2022 15:30:38.000; NORMALBOLUSAMOUNTPROGRAMMED = 1. 09/23/2022 15:30:38.000; BOLUSAMOUNTDELIVERED = 1. 09/23/2022 17:13:32.000; NORMALBOLUSDELIVERED. 09/23/2022 17:13:32.000; NORMALBOLUSAMOUNTPROGRAMMED = 4. 09/23/2022 17:13:32.000; BOLUSAMOUNTDELIVERED = 4. 09/23/2022 17:22:42.000; NORMALBOLUSDELIVERED. 09/23/2022 17:22:42.000; NORMALBOLUSAMOUNTPROGRAMMED = 1.5. 09/23/2022 17:22:42.000; BOLUSAMOUNTDELIVERED = 1.5. 09/23/2022 19:34:54.000 ; NORMALBOLUSDELIVERED. 09/23/2022 19:34:54.000 ; NORMALBOLUSAMOUNTPROGRAMMED = 8.2. 09/23/2022 19:34:54.000 ; BOLUSAMOUNTDELIVERED = 8.2. 09/23/2022 20:34:26.000; NORMALBOLUSDELIVERED. 09/23/2022 20:34:26.000; NORMALBOLUSAMOUNTPROGRAMMED = 3.4. 09/23/2022 20:34:26.000; BOLUSAMOUNTDELIVERED = 3.4. 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. 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. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (22.3 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND DKA. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    THE CUSTOMERS REPORTED VIA PHONE CALL THAT CUSTOMER WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2022. BLOOD GLUCOSE READING WAS OVER 538 MG/DL AT TIME OF HOSPITALIZATION. CUSTOMER REPORTED THAT THEY HAD A SYMPTOMS LIKE VOMITING, ABDOMINAL PAIN DUE TO HIGH BLOOD GLUCOSE. CUSTOMER REPORTED THEY HAD HEADACHE, EXTREMITY PAIN , CRAMPS, AND INCREASED THIRST AT TIME OF HOSPITALIZATION. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN DRIP AND MANUAL INJECTION OR INSULIN PEN FOR HIGH BLOOD GLUCOSE. AUTO MODE FEATURE WAS ACTIVE AT TIME OF EVENT. CUSTOMER ALSO REPORTED THAT INSULIN PUMP WAS UNDER DELIVERING. NO FURTHER PATIENT COMPLICATION WERE REPORTED. DEVICE WAS RETURN FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2724490 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL NG3162319H 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization FRN-MMT-326-RSVR, UNOMED SET