BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 10161673 · Received June 17, 2020

    Report

    Report Number
    2032227-2020-132227
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    June 9, 2020
    Report Date
    June 29, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 0.0873 INCHES. THE PUMP POWERED UP PROPERLY AFTER THE TEST BATTERY WAS INSTALLED. THE PUMP WAS MONITORED FOR 2 DAYS. NO BLANK DISPLAY NOTED DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED CASE AT THE BATTERY TUBE SIDE, PILLOWING KEYPAD OVERLAY, SCRATCHED KEYPAD OVERLAY AND CRACKED RETAINER. 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. PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 09-JUN-2020 IN THE PUMP HISTORY FILE (ON PRIMARY SVN 000311335964). 06/06/2020 22:27:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW BATTERY ALERT (104) 06/07/2020 07:58:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = CHANGE BATTERY FAULT (73) 06/07/2020 08:08:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = CHANGE BATTERY FAULT (73) 06/07/2020 08:29:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = OFF NO POWER (11) 06/07/2020 08:39:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = OFF NO POWER (11) 06/07/2020 08:40:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) 06/07/2020 08:40:28.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT (6) THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO PUMP ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM, REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM NOTED DURING TESTING. THE TEST BATTERY WAS REMOVED AND REINSERT IN LESS THAN 1 MINUTE INTO THE BATTERY COMPARTMENT. NO UNEXPECTED PUMP ERROR 23 OR BATTERY OUT LIMIT ALARM NOTED DURING TESTING OR AFTER THE BATTERY CHANGE. LOW BATTERY ALERT NOT CONFIRMED. CHANGE BATTERY FAULT (73)/REPLACE BATTERY ALERT NOT CONFIRMED. OFF NO POWER (11)/REPLACE BATTERY NOW ALARM NOT CONFIRMED. PUMP ERROR 23 NOT CONFIRMED. BATT OUT LIMIT (6) NOT CONFIRMED. UNABLE TO PERFORM THE HISTORY REVIEW 1 WEEK PRIOR TO THE EVENT DATE 26-APR-2023 IN THE PUMP HISTORY FILE DUE TO NO DATA AVAILABLE (ON SVN 000315652854). PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED DKA/HIGH BGS. BLANK DISPLAY 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 · 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2020, WITH BLOOD GLUCOSE OF 500 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS AND INSULIN SHOTS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625112 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG37W3P 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Hospitalization FRN-MMT-332-RSVR, UNOMED INF SET| FRN-MMT-332-RSVR, UNOMED INF SET