BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)

    MDR report key: 12924747 · Received December 2, 2021

    Report

    Report Number
    MW5105753
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 30, 2021
    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. PATIENT DENIES ANY SEVERE DEHYDRATION OR WATER LOSS AT THE TIME OF DISCORDANT READINGS. PATIENT ALSO DENIES HIGH DOSE ASCORBIC ACID OR SALICYLIC ACID USE AND PATIENT DENIES ANY RECENT MRI/CT/X-RAY/HOT TUB/SAUNA USE THROUGH WHICH THE SENSOR WAS WORN. PATIENT IS NOT ON DIALYSIS AND DOES NOT HAVE A PACEMAKER. PATIENT STATED THIS HAS OCCURRED WITH MULTIPLE SENSORS. HE WAS USING HIS PHONE AS THE READER. READINGS WITH THE FREESTYLE LIBRE 14 DAY CGM ARE AS BELOW: DATE TIME FINGERSTICK BG READING FREESTYLE LIBRE CGM SYSTEM READING: (B)(6) 2021 2212; 152/163, (B)(6) 2021 940:139/70, (B)(6) 2021, 2135: 195/178; (B)(6) 2021, 949:97/70; (B)(6) 2021, 1200:247/225, (B)(6) 2021, 2318: 164/162, (B)(6) 2021, 1010: 90/50. PATIENT WAS THEN SWITCHED TO DEXCOM G6 CGM. READINGS APPEARED TO MATCH BETTER AS BELOW. DATE TIME FINGERSTICK BG READING DEXCOM G6 CGM SYSTEM READING: (B)(6) 2021 AT 11 AM, 146/121, (B)(6) 2021, AT 1130 PM: 122/114; (B)(6) 2021 920 AM, 104/104; (B)(6) 2021 1130 PM: 247/237; (B)(6) 2021 9 AM, 163/161; (B)(6) 2021 8 PM, 316/331. SUSPECT DRUG# I DOSING: USE 1 SENSOR EVERY 14 DAYS FOR BLOOD GLUCOSE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816618 GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY) SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED PZE ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male