BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 13750359 · Received March 12, 2022

    Report

    Report Number
    2032227-2022-130817
    Event Type
    Malfunction
    Date Received
    March 12, 2022
    Date of Event
    March 11, 2021
    Report Date
    August 9, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. (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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. THE CUSTOMER ALLEGED INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM ON 11-MAR-2021. ON SVN 000314190111 THE CUSTOMER ALLEGED PUMP ERROR 38 ON 24-APR-2022. DEVICE WAS RECEIVED WITH PUMP ERROR 38 ALARM DURING THE REWIND TEST. UNABLE TO TEST FOR INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM DUE TO CONSTANT PUMP ERROR 38 ALARM. THERE WAS 35 PUMP ERROR 38 LISTED IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE FIRST 10 PUMP ERROR 38 ;LISTED IN THE PUMP HISTORY FILE. 04/24/2022 07:49:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK MOTOR ALARM (38) 04/24/2022 07:50:20.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK MOTOR ALARM (38) 04/24/2022 07:50:56.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK MOTOR ALARM (38) 04/24/2022 07:51:44.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK MOTOR ALARM (38) 04/24/2022 07:52:36.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK MOTOR ALARM (38) 04/24/2022 07:53:33.000. ALARMALERTNOTIFICATION FAULTNUMBER = STUCK MOTOR ALARM (38) 04/24/2022 07:55:45.000. ALARMALERTNOTIFICATION FAULTNUMBER = STUCK MOTOR ALARM (38) 04/24/2022 09:08:24.000. ALARMALERTNOTIFICATION FAULTNUMBER = STUCK MOTOR ALARM (38) 04/24/2022 09:08:53.000. ALARMALERTNOTIFICATION FAULTNUMBER = STUCK MOTOR ALARM (38) 04/24/2022 09:09:34.000. ALARMALERTNOTIFICATION FAULTNUMBER = STUCK MOTOR ALARM (38). DEVICE HAD CONSTANT PUMP ERROR 38 ALARM (THE TIMES AND DATE LISTED ABOVE) DURING THE REWIND TEST DUE TO CORRODED MOTOR HOME SWITCH CAUSING THE MOTOR SLIDE TO REWIND PAST THE MOTOR HOME SWITCH AND REMAINING STUCK AGAINST THE MOTOR HOUSING. UNABLE TO PERFORM THE PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT DUE TO CONSTANT PUMP ERROR 38 ALARM. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, AND STAINED KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS. THERE WAS NO "NO DELIVERY ALARM" NOTED IN THE PUMP HISTORY FILE. DURING VISUAL INSPECTION, NO DAMAGE NOTED ON THE ELECTRONIC ASSEMBLY, OR FORCE SENSOR. INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM WAS UNKNOWN. PUMP ERROR 38 WAS 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT NO DELIVERY/OCCLUSION ALARM DURING THERAPY OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177956 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4ZA59 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown