BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2)

    MDR report key: 14601632 · Received June 3, 2022

    Report

    Report Number
    MW5110101
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    February 9, 2022
    Report Date
    May 27, 2022
    Manufacturer
    ABBOTT DIABETES CARE, INC.
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS STARTED ON FREESTYLE LIBRE 2 GLUCOSE SENSOR IN 03/2021. PATIENT REPORTED INCONGRUENT READINGS WITH SENSOR COMPARED TO FINGERSTICK READINGS. PATIENT STATES HE IS PLACING THE APPLICATOR AND SENSOR PACK TOGETHER ON A FIRM SURFACE. PATIENT ENDORSES APPROPRIATE APPLICATION TECHNIQUE. PATIENT DID STATE HE WAS STORING HIS SENSORS IN THE BATHROOM CLOSET AS OPPOSED TO A COOL, DRY PLACE. HE DENIES THE SENSOR BEING EXPIRED. HE DENIED SEVERE DEHYDRATION, WATER LOSS, OR BEING CRITICALLY ILL AT THE TIME OF INCONGRUENT READINGS. HE DENIED HIGH DOSE ASCORBIC ACID OR SALICYLIC ACID USE. HE DENIED RECENT MRI/CT/X-RAY/HOT TUB/SAUNA USE WITH SENSOR, BEING ON DIALYSIS, OR HAVING A PACEMAKER. HE DID NOT HAVE THE LOT NUMBER OF THE NON-WORKING SENSOR. HE STATES HE HAD ISSUES WITH MULTIPLE SENSORS. HE DID NOT REPLACE THE READER DEVICE. HIS BLOOD GLUCOSE TESTS ARE NOT EXPIRED. DATE TIME FINGERSTICK BG READING FREESTYLE LIBRE CGM SYSTEM READING 02/2022 AM 192 242, 02/2022 OVERNIGHT 132 64, 02/2022 152 213, (B)(6) 2022 AM 172 131. PATIENT DENIES TAKING THESE ABOVE READINGS RIGHT AFTER EATING, DOSING INSULIN, OR EXERCISING. PATIENT WAS SWITCHED TO DEXCOM G6 (B)(6) 2022 AND READINGS ARE AS BELOW. DATE TIME PRODIGY DEXCOM (B)(6) 2022 10:00PM 215 170, (B)(6) 2022 6:00AM 160 125 146 CALIB (B)(6) 2022 5:29 PM 192 169 181 CALIB, (B)(6) 2022 7:08 AM 239 247, (B)(6) 2022 9: L 9 AM 207 175, (B)(6) 2022 12:51 PM 179 189, (B)(6) 2022 10:32 AM 137 115, 4/13/2022 8:58 AM 120 140, (B)(6) 2022 9:44 AM 169 160, (B)(6) 2022 12:30 PM 155 169. SUSPECT DRUG# 1, DOSING: USE 1 SENSOR EVERY 14 DAYS. DATES OF USE: (B)(6) 2021 - (B)(6) 2022. DIAGNOSIS FOR USE: DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2810368 GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2) SENSOR, GLUCOSE, INVASIVE MDS ABBOTT DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male