BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 7959118 · Received October 12, 2018

    Report

    Report Number
    2032227-2018-41547
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 27, 2018
    Report Date
    May 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Removal / Correction Number
    Z-0956-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED THE FULL FUNCTIONAL TEST INCLUDING THE DISPLACEMENT TEST, REWIND, PRIME TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST. SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT WITHIN SPECIFICATIONS. THE INSULIN PUMP POWERED UP PROPERLY AFTER INSERTION OF THE BATTERY. PERFORMED A SAFE SHUT DOWN OF THE PUMP AND THEN POWERED THE PUMP BACK ON. NO UNEXPECTED POST-RESET RAM CRC ALARM OR THIS ALARM IS GENERATED WHEN A POWER FAILURE IS DETECTED ALARMS WERE NOTED. DEVICE RECEIVED WITH CRACKED RETAINER.

    Description of Event or Problem · 1

    CUSTOMER'S MOM REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 269 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER ASSISTED WITH INSULIN PUMP RESET PROCEDURE. CUSTOMER STATED THAT THE INSULIN PUMP SCREEN TURNED OFF. CUSTOMER WAS ABLE TO CLEAR THE PUMP ERRORS AND POWER LOSS ALARM OCCURRED AND PROGRAM THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP HAD ERROR POST-RESET RAM CRC ALARM AFTER THE RESET. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO REWIND THE PUMP. CUSTOMER STATES THE ALARM OCCURRED IMMEDIATELY AFTER A BATTERY CHANGE. CUSTOMER STATED THAT THE INSULIN PUMP ERROR POST-RESET RAM CRC ALARM HAS OCCURRED MORE THAN ONCE AFTER A BATTERY CHANGE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801469 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2T6AW 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female