BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 7523198 · Received May 17, 2018

    Report

    Report Number
    3013756811-2018-16196
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    January 2, 2018
    Report Date
    May 17, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE T:SLIM X2 USER GUIDE, ¿ STORE THE DEXCOM G5 MOBILE CGM SENSOR AT TEMPERATURE BETWEEN 36°F TO 77°F FOR THE LENGTH OF THE SENSOR¿S SHELF LIFE. STORING THE SEN¬SOR IMPROPERLY MIGHT CAUSE THE SENSOR GLUCOSE READINGS TO BE INACCURATE, AND YOU MIGHT MISS SEVERE HYPOGLYCEMIA (LOW BLOOD GLUCOSE) OR HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) EVENTS.¿ NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS MULTIPLE INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READING WAS 180-224 MG/DL, AND THE METER BG READING WAS 72-194 MG/DL. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. REPORTEDLY, THE CUSTOMER DID NOT STORE THE SENSOR ACCORDING TO MANUFACTURE RECOMMENDATIONS. A REPLACEMENT SENSOR WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364275 T:SLIM G4 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC DEXCOM, INC. 9500-27 5232570

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR