BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 12622571 · Received October 13, 2021

    Report

    Report Number
    2032227-2021-204694
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    October 9, 2021
    Report Date
    March 24, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000367053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK.CUSTOMER RETURNED PUMP FOR AN ALLEGED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM FOUND ON OCT 09, 2021. NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING BOOT UP. PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST AND DISPLACEMENT ACCURACY TEST DUE TO A CONSTANT PUMP ERROR 38 ALARM DURING THE REWIND TEST. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (VARIABLE NFO = 15) WERE RECORDED AND FOUND IN THE FORMATTED HISTORY FILES ON 10/09/2021 22:00:01.000 DUE TO RF DRIVER ANOMALY, SUSPECTED ON HW. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND A JAMMED MOTOR GEAR BOX. CORROSION WAS FOUND ON THE ELECTRONIC ASSEMBLY, VIBRATOR AND BATTERY TUBE ASSEMBLY. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR AND MOTOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.4 MVOLTS). A TEST MOTOR WAS USED AND CONTINUED TESTING. THE PUMP PASSED THE REWIND TEST. IN CONCLUSION, THE PUMP HAD A CONSTANT PUMP ERROR 38 ALARM DUE TO A JAMMED MOTOR GEAR BOX. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. PUMP ERROR 38 ALARM WAS CONFIRMED. PUMP ERROR 38 ALARM DUE TO A JAMMED MOTOR GEAR BOX. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS CONFIRMED DUE TO PUMP ERROR 4 AND PUMP ERROR 63 ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM DUE TO CORROSION ON THE ELECTRONIC ASSEMBLY. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON THE VIBRATOR AND BATTERY TUBE ASSEMBLY. 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

    (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 · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SHOWED AN OPEN BOOK IMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526875 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG5BEVR 000000763000367053

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female