BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782KL 670G MM RPL

    MDR report key: 18966846 · Received March 25, 2024

    Report

    Report Number
    2032227-2024-146741
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 15, 2024
    Report Date
    August 6, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283599
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT POWER UP PROPERLY AFTER BATTERY INSTALLATION. UNIT WAS DOWNLOADED SUCCESSFULLY USING (THUS SOFTWARE) FOR REFERENCE. THE ADAPT TOOL WAS UTILIZED TO SEARCH FOR ANY ALARMS THAT MAY HAVE OCCURRED IN THE PAST OR AROUND THE COMPLAINT DATE THAT MIGHT OF TRIGGER THE REASON COMPLAIN. PROCEED IT WITH THE FOLLOWING TESTING TO ASSURE PROPER FUNCTIONALITY OF THE UNIT. PUMP PASSED SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND HIGH AND LOW CURRENT MEASUREMENT TEST. NO UNEXPECTED CRITICAL PUMP ERROR (OPEN BOOK) DURING TESTING. THE ADAPT TOOL REVEALS THAT ON (B)(6) 2024 AT 15:52:01.000 PUMP ERROR 3 WAS RECORDED. FILE NUMBER: (B)(4) LINE NUMBER: (B)(4). THE ADAPT TOOL ALSO RECORDED PUMP ERROR 23, 68 AND 49. PER SOFTWARE ENGINEERING LOG, CRITICAL PUMP ERROR (OPEN BOOK IMAGE) WAS CAUSE BY A PUMP ERROR 3. PUMP ERROR 3 WAS CAUSE BY PIO HIGH WAS NOT RAISED DURING EXPECTED TIME-OUT (100 MILLI SEC) OR THE ACK WASN'T RECEIVED DURING TIME-OUT (100 MILLI SEC). PROCEEDED BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION ON CONNECTORS AND ELECTRONIC ASSEMBLY. ALL CONNECTORS WERE PLUGGED IN PROPERLY. HOWEVER, DURING DECONSTRUCTIVE ANALYSIS DURING VISUAL INSPECTION CORRODED ELECTRONIC ASSEMBLY WAS NOTED CAUSING AN INTERMITTENT ELECTRICAL SHORT. UNIT ALSO RECEIVED WITH LABEL DAMAGE (FADED), BATTERY TUBE THREADS - CRACKED, CRACKED CASE (BATTERY TUBE), SCRATCHED CASE AND CRACKED KEYPAD OVERLAY. IN CONCLUSION, CUSTOMER ALLEGATIONS ARE NOT CONFIRMED. UNIT POWERED UP PROPERLY AFTER BATTERY INSTALLATION AND WAS TESTED SUCCESSFULLY. HOWEVER, DURING DOWNLOAD REVIEW PUMP ERROR 3 WAS RECORDED DUE TO PIO HIGH WAS NOT RAISED DURING EXPECTED TIME-OUT (100 MILLI SEC) OR THE ACK WASN'T RECEIVED DURING TIME-OUT (100 MILLI SEC). PROBLEM ISOLATED TO ELECTRONIC ASSEMBLY DUE TO MOISTURE DAMAGE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED CRITICAL PUMP ERROR (OPEN BOOK IMAGE). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S)(B)(6) CUSTOMER REPORTED A CRITICAL PUMP ERROR OTHER THAN THE OPEN BOOK IMAGE ERROR . THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS . (B)(6) WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27442 PUMP MMT-1782KL 670G MM RPL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782KL NG3267878H 000000763000283599

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown