BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12230710 · Received July 27, 2021

    Report

    Report Number
    2032227-2021-172639
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    July 16, 2021
    Report Date
    October 21, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    P-CAP OR RESERVOIR LOCKS PROPERLY INTO PLACE. DEVICE RECEIVED WITH A FROZEN DISPLAY WITH FLASHING MEDTRONIC LOGO. RESET THE INSULIN PUMP THREE TIMES TO DETERMINE FLASHING MEDTRONIC LOGO IS PERMANENT. FROZEN DISPLAY OCCURRED DUE TO SEVERE MOISTURE DAMAGE AT THE ELECTRONIC ASSEMBLIES. FORCE SENSOR IS OUT OF SPECIFICATION. SWAPPED PCB 1 WITH A TEST BOARD, AND FROZEN DISPLAY STILL OCCURRED DUE TO SEVERE MOISTURE DAMAGE AT THE ELECTRONIC ASSEMBLIES. DEVICE UNABLE TO PERFORM DISPLACEMENT TEST, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST OR VERIFY CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM DUE TO FROZEN DISPLAY ANOMALY. UNABLE TO DOWNLOAD INSULIN PUMP'S HISTORY AND TRACE FILES DUE TO FROZEN DISPLAY ANOMALY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHES ON CASE. 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.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 452 MG/DL TREATED WITH A MANUAL INJECTION. CUSTOMER HAD RECEIVED OPEN BOOK IMAGE ALARM. AUTO MODE FEATURE INFORMATION WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128061 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4GA2Q 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other UNK-FRN-RSVR, UNK-UNOMED INF SET.