BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 13148489 · Received January 4, 2022

    Report

    Report Number
    2032227-2022-100435
    Event Type
    Injury
    Date Received
    January 4, 2022
    Date of Event
    December 25, 2021
    Report Date
    May 30, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    RETAINER = BLACK. THE CUSTOMER ALLEGED THE PUMP IS OVER DELIVERING CAUSING LOW BGS ON 12/25/2021. 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 .08700 INCHES. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. NO OVER 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, STAINED KEYPAD OVERLAY, AND PILLOWING KEYPAD OVERLAY. THE PUMP PASSED ALL FUNCTIONAL TESTING. OVER DELIVERY AND LOW BG ANOMALIES ARE NOT CONFIRMED. THE FORMATTED HISTORY FILE LIST THE FOLLOWING MANUAL PROGRAMMED BOLUS DELIVERIES FOR 12/25/2021: 12/25/2021 01:57 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 2.6 BOLUSAMOUNTDELIVERED = 2.6. 12/25/2021 02:10 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 5 BOLUSAMOUNTDELIVERED = 5. 12/25/2021 02:14 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 3 BOLUSAMOUNTDELIVERED = 3. 12/25/2021 06:46 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 0.5 BOLUSAMOUNTDELIVERED = 0.5. 12/25/2021 09:18 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 1 BOLUSAMOUNTDELIVERED = 1. 12/25/2021 09:29 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 5 BOLUSAMOUNTDELIVERED = 5. 12/25/2021 10:14 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 5 BOLUSAMOUNTDELIVERED = 5. 12/25/2021 13:21 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 9.4 BOLUSAMOUNTDELIVERED = 9.4. 12/25/2021 13:52 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 10 BOLUSAMOUNTDELIVERED = 10. 12/25/2021 14:30 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 10 BOLUSAMOUNTDELIVERED = 10. 12/25/2021 16:00 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 5 BOLUSAMOUNTDELIVERED = 5 . 12/25/2021 16:37 MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 6 BOLUSAMOUNTDELIVERED = 6. 12/25/2021 18:13 BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 10 BOLUSAMOUNTDELIVERED = 10. 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.

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 20 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER'S CURRENT BLOOD GLUCOSE VALUE WAS 57 MG/DL. CUSTOMER STATED WAS TREATED WITH FOOD AND GLUCOSE TABLETS. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS SHAKING MENTAL CONFUSION AND WEAKNESS. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER STATED THAT THE AUTO MODE FEATURE WAS NOT ACTIVE AT TIME OF LOW BLOOD GLUCOSE EVENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88076 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5Q9U4 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Other FRN-UNK-RSVR, UNOMED