BEUDAMED
    FDA Adverse Event Injury Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 12874464 · Received November 25, 2021

    Report

    Report Number
    2032227-2021-222583
    Event Type
    Injury
    Date Received
    November 25, 2021
    Date of Event
    October 29, 2021
    Report Date
    May 8, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SELF TEST, DISPLACEMENT ACCURACY TEST, SLEEP CURRENT MEASUREMENT, AND ACTIVE CURRENT MEASUREMENT. INTERMITTENT BUTTON RESPONSE NOTED DURING TESTING. THE INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND FLATTENED KEYPAD DOME (NO CREASE). SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. NO STUCK KEY ALARMS NOTED DURING TESTING, HOWEVER, A STUCK KEY ALARM WAS FOUND IN THE HISTORY FILE ON (B)(6) 2021 AT 23:41:29, 23:51:00 AND (B)(6) 2021 AT 06:05:35, 06:15:00. THE INSULIN PUMP PASSED THE KEYPAD VOLTAGE TEST. UNABLE TO CONFIRM HIGH BLOOD GLUCOSE. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, AND SCRATCHED CASE WERE NOTED DURING VISUAL INSPECTION. IN SUMMARY, CUSTOMER ALLEGATION FOR COSMETIC DAMAGE (DAMAGED BATTERY COMPARTMENT) WAS NOT CONFIRMED DURING VISUAL INSPECTION, HOWEVER, OTHER COSMETIC DAMAGE WAS NOTED. KEYPAD UNRESPONSIVE / BUTTON ERROR ALARM CONFIRMED DUE TO FLATTENED KEYPAD DOME. UNABLE TO CONFIRM ALLEGED HIGH BLOOD GLUCOSE. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A ISSUE WITH BUTTONS ON KEYPAD. THE CUSTOMER'S MOTHER REPORTED PHYSICAL DAMAGE TO KEYPAD AND BACK OF THE INSULIN PUMP ALONG THE BATTERY SIDE. CUSTOMER'S MOTHER STATED THAT INSULIN PUMP STOPPED DELIVERY AND CUSTOMER HAD HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL REPORTED AT THE TIME OF INCIDENT WAS 29 MMOL/L. CUSTOMER'S MOTHER TREATED HIGH BLOOD GLUCOSE WITH PEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772116 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG41UCY 000000763000317089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown