BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 16425378 · Received February 23, 2023

    Report

    Report Number
    2032227-2023-162706
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    February 5, 2023
    Report Date
    March 24, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. S/W 4.11E RETAINER RING = BLACK CASE TYPE = NGP. THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BGS/DKA/LOW BGS AND CHEST PAIN ON 05-FEB-2023. ON SVN (B)(6) THE CUSTOMER ALLEGED INSULIN FLOW BLOCK ALARM ON 27-JAN-2023. ON SVN (B)(6) HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 464 MG/DL ON 05-FEB-2023. THE PUMP 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 AT 0.0875 INCHES. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE NO DELIVERY ALARM LISTED IN THE PUMP HISTORY FILE ON THE EVENT DATE 27-JAN-2023 FOR SVN (B)(6). 01/27/2023 01:50:37.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS 01/27/2023 02:02:45.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS 01/27/2023 02:05:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 02:07:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 02:22:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 02:25:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 02:27:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 02:38:06.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS 01/27/2023 02:40:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 02:50:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 02:51:30.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS 01/27/2023 02:52:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 03:02:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 03:05:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 05:18:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS 01/27/2023 15:50:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS 01/27/2023 16:26:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS 01/27/2023 16:40:55.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS 01/27/2023 16:51:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL 01/27/2023 16:54:07.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BASAL THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS/DKA/LOW BGS/HYPERGLYCEMIA. INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM WAS NOT CONFIRMED. 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. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 464 MG/DL. TROUBLESHOOTING WAS PARTIALLY PERFORMED. IT WAS FOUND THAT THE CUSTOMER GOT A MILD HEART ATTACK AND WAS TAKEN IN THE AMBULANCE AND ADMITTED TO THE CARDIAC ICU. THE CUSTOMER WAS HOSPITALIZED AND GIVEN AN IV DRIP FOR HIGH BLOOD GLUCOSE. IT WAS UNKNOWN IF THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. THE AUTO-MODE FEATURE WAS ACTIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708619 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5TCJ0 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| O