BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12171976 · Received July 15, 2021

    Report

    Report Number
    2032227-2021-167849
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    July 6, 2021
    Report Date
    April 28, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000190460
    Removal / Correction Number
    Z-0956-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PASSED SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, SELF TEST AND DISPLACEMENT TEST. NO PUMP ERROR 3, PUMP ERROR 53, FAILED BATTERY TEST OR PUMP ERROR 23 NOTED DURING TEST. HOWEVER, DEVICE RECEIVED WITH CORRODED BATTERY TUBE. DEVICE SUCCESSFULLY DOWNLOADED TO THUS. DEVICE TRACE DOWNLOAD ANALYSIS CONFIRMED THE INSULIN PUMP ALARMED FAILED BATTERY TEST ON (B)(6) 2021 23:57:04.000, PUMP ERROR 23 ON (B)(6) 2021 00:21:08.000, POWER LOSS ALARM ON (B)(6) 2021 00:25:44.000 AND LOW BATTERY ALERT ON (B)(6) 2021 23:54:00.000. THE POWER MANAGEMENT GRAPH CONFIRMED DEVICE POWER LOSS ALARM AND LOW BATTERY ALERT DUE TO MOISTURE DAMAGED TO ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2. THE FORMATTED HISTORY FILE CONFIRMED INSULIN PUMP ALARMED PUMP ERROR 3 ON (B)(6) 2021 00:24:19.000 AND PUMP ERROR 53 ON (B)(6) 2021 00:11:47.000 (LINE NUMBER 5632 FILE NUMBER 2005) DUE TO SOFTWARE ERROR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, CORRODED BATTERY TUBE, CORRODED MOTOR HOME SWITCH, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED BATTERY TUBE THREADS, CRACKED KEYPAD OVERLAY, CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT AND CRACKED RETAINER. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. 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

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0956-2020. 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). 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MULTIPLE INSULIN PUMP ERRORS. CUSTOMER STATED THAT THEIR INSULIN PUMP FAILED AND IT CAME WITH BATTERY FAILED. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM BUT WERE NOT ABLE TO COMPLETE THE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075117 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2UYFW 000000763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male