BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)

    MDR report key: 14357647 · Received May 10, 2022

    Report

    Report Number
    MW5109619
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    February 17, 2022
    Report Date
    April 27, 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

    PATIENT WAS STARTED ON FREESTYLE LIBRE 14 DAY CGM SYSTEM ~(B)(6) 2020. PATIENT RECENTLY REPORTED INCONGRUENT READINGS BETWEEN FREESTYLE LIBRE 14 DAY AND FINGERSTICK BLOOD GLUCOSE READINGS. PATIENT REPORTED APPROPRIATE SENSOR PACK CONSTRUCTION AND APPLICATION TECHNIQUE, APPROPRIATE SENSOR STORAGE, AND USE OF IN DATE SENSORS. PATIENT DENIED SEVERE DEHYDRATION OR WATER LOSS DURING INCONGRUENT READINGS. PATIENT DENIED USE OF HIGH DOSE ASCORBIC ACID OR SALICYLIC ACID. PATIENT STATED HE DID NOT TAKE THE SENSOR THROUGH AN MRI/CT SCAN/X-RAY/HOT TUB/SAUNA. PATIENT IS NOT ON DIALYSIS AND DOES NOT HAVE A PACEMAKER. PATIENT DID NOT HAVE THE LOT NUMBER OF THE NON-WORKING SENSOR AVAILABLE. PATIENT SAID THIS HAS HAPPENED WITH MULTIPLE SENSORS. WE ALSO VERIFIED THAT TEST STRIPS WERE IN DATE. FREESTYLE LIBRE CGM READINGS: DATE TIME - FINGERSTICKFREESTYLE LIBRE (B)(6) 2022 10 PM, 164 45; (B)(6) 2022 1135 AM 157 49; (B)(6) 2022 1020 AM 247 123; (B)(6) 2022, 12 PM 100 56; (B)(6) 2202 1033 AM 105 64; (B)(6) 2022 3 PM 189 107; (B)(6) 2022 226 PM 151 54. PATIENT DENIED ANY OF THE ABOVE READINGS BEING TAKEN RIGHT AFTER EATING, DOSING INSULIN, OR EXERCISING. PATIENT WAS CONVERTED TO DEXCOM G6 CGM. READINGS ARE AS BELOW. DATE TIME: FINGERSTICK DEXCOM G6 CGM (B)(6) 2022 930 AM, 87 100; (B)(6) 2022 1230 PM 216 183; (B)(6) 2022 1205 PM 106 110; (B)(6) 2022 205 PM 88 86; (B)(6) 2022 12 PM 164 159; (B)(6) 2022 320 PM 160 166; (B)(6) 2022 630 PM 76 79. SUSPECT DRUG# 1 DOSING: USE 1 SENSOR UNDER THE SKIN EVERY 14 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870949 GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY) FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male