BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)

    MDR report key: 13206696 · Received January 7, 2022

    Report

    Report Number
    MW5106536
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    November 18, 2021
    Report Date
    January 3, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT WAS PRESCRIBED THE FREESTYLE LIBRE 14 DAY CGM. PT REPORTED INCONGRUENT READINGS BETWEEN FINGERSTICK AND CGM READINGS. AUTHOR SPOKE WITH PT. PT ENDORSED APPROPRIATE APPLICATOR / SENSOR PACK CONSTRUCTION, APPROPRIATE APPLICATION TECHNIQUE, AND APPROPRIATE SENSOR STORAGE. PT DENIES ANY SEVERE DEHYDRATION OR WATER LOSS AT THE TIME OF DISCORDANT READINGS. PT ALSO DENIES HIGH DOSE ASCORBIC ACID OR SALICYLIC ACID USE AND PT DENIES ANY RECENT MRI / CT / X-RAY / HOT TUB / SAUNA USE THROUGH WHICH THE SENSOR WAS WORN. PT IS NOT ON DIALYSIS AND DOES NOT HAVE A PACEMAKER. PT STATED THIS HAS OCCURRED WITH MULTIPLE SENSORS. PT WAS USING EXPIRED BLOOD GLUCOSE TEST STRIPS SO AUTHOR PROVIDED PT WITH NEW TEST STRIPS. PT COMPARED BG READINGS FROM EXPIRED TEST STRIPS WITH NEW TEST STRIPS AND PER PT, READINGS WERE SIMILAR BETWEEN THE TWO. READINGS WITH THE FREESTYLE LIBRE 14 DAY CGM ARE AS BELOW. DATE TIME FINGERSTICK BG READING FREESTYLE LIBRE CGM SYSTEM READING ON (B)(6) 2021 430PM: 99 63, (B)(6) 2021 AT 830 PM 96 49, (B)(6) 2021 AT 6 AM 101 LO, (B)(6) 2021 AT 930 AM 146 91, (B)(6) 2021 AT 1130 AM 106 LOW. PT WAS SWITCHED TO DEXCOM G6 CGM. READINGS WERE AS BELOW: DATE TIME FINGERSTICK BG READING DEXCOM CGM SYSTEM READING: (B)(6) 2021 AT 1130 AM 132 143, (B)(6) 2021 AT 510 PM 103 109, (B)(6) 2021 AT 3 PM 255 216 "(B)(6) 2021" 830 AM 180 188, "(B)(6) 2021" AT 1130 AM 132 130. DOSING: USE 1 SENSOR EVERY 14 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476096 GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY) SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED PZE ABBOTT DIABETES CARE INC.
    2476097 FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE PZE ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male