BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7

    MDR report key: 22062799 · Received May 21, 2025

    Report

    Report Number
    MW5170680
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 15, 2025
    Report Date
    May 17, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CGM(CONTINUOUS GLUCOSE MONITOR) DELAMINATED FROM ITS ADHESIVE ATTACHMENT AND ITS WIDER "DONUT" ADHESIVE OVER ATTACHMENT. IT WAS NOT STRUCK OR PULLED FROM THE ADHESIVE WHILE DONNING OR DOFFING APPAREL, FOR EXAMPLE; IT JUST DROPPED TO THE FLOOR AFTER DAY FIVE (5) OUT OF TEN- (10-) DAY-USE CYCLE. SINCE INSURANCE ONLY ALLOWS NINE (9) DEVICES PER 90-DAY PERIOD, I HAVE LIMITED GLUCOSE CONTROL FOR AN INSULIN PUMP WITHOUT USING A LANCET WITH GLUCOSE-MONITOR STRIPS. THESE CGMS ARE TOO EXPENSIVE TO PAY OUT OF POCKET AND DETACHING FROM ITS ADHESIVE SUBSTRATE CONGERS POOR QUALITY AND RELIABILITY FROM THE PRODUCTION FLOOR. DEXCOM G7 CGM, REF: STP-AT-012, LOT: 1725058001 (01): (B)(4) (11): 250501 (17): 260731 (21): (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366783 G7 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC. G7 1725058001

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male 81MG ASPIRIN| ALLEGRA| EFFEXOR| HCTZ| KIRKLAND-BRAND ADULT MULTIVITAMIN GUMMIES| KIRKLAND-BRAND CALCIUM| KIRKLAND-BRAND VITAMIN D3 (2000IU)| LOSARTAN | NOVOLOG| SIMVASTATIN | SYNTHROID| TANDEM TSLIM X2 INSULIN PUMP | WELLBUTRIN XR| ZINC