BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 12738811 · Received November 2, 2021

    Report

    Report Number
    2954323-2021-90978
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    October 13, 2021
    Report Date
    November 10, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. CLINICAL AND STABILITY WERE REVIEWED AND CONFIRMED THAT LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR LIBRE SENSORS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD HAVE LEAD TO THE COMPLAINT. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND FS LIBRE SENSORS, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.THIS SERVES AS A CORRECTION. THE INITIAL MDR (EMDR-213423) WAS GENERATED AND SUBMITTED UNDER THE INCORRECT ISSUES.

    Description of Event or Problem · 0

    A LOW READINGS ISSUE WAS REPORTED WITH THE USE OF THE ADC FREESTYLE LIBRE SENSOR. A CALLER REPORTED CUSTOMER RECEIVED UNSPECIFIED LOW SENSOR SCANS AND EXPERIENCED SYMPTOMS DESCRIBED AS ¿BODY WAS NOT ABLE TO MOVE FOR 30 MIN¿, SWEATING, AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND RECEIVED SWEETS AND ORANGE JUICE FROM THE CAREGIVER AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. CLINICAL AND STABILITY WERE REVIEWED AND CONFIRMED THAT LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR LIBRE SENSORS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD HAVE LEAD TO THE COMPLAINT. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND FS LIBRE SENSORS, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A LOW READINGS ISSUE WAS REPORTED WITH THE USE OF THE ADC FREESTYLE LIBRE SENSOR. A CALLER REPORTED CUSTOMER RECEIVED UNSPECIFIED LOW SENSOR SCANS AND EXPERIENCED SYMPTOMS DESCRIBED AS ¿BODY WAS NOT ABLE TO MOVE FOR 30 MIN¿, SWEATING, AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND RECEIVED SWEETS AND ORANGE JUICE FROM THE CAREGIVER AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637098 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention