BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 8759705 · Received July 3, 2019

    Report

    Report Number
    2954323-2019-05195
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 20, 2019
    Report Date
    November 15, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. CLINICAL DATA WAS 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, THE CASE WILL BE RE-OPENED AND A PHYSICAL INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    A LOW READINGS ISSUE WAS REPORTED WITH THE ADC FREESTYLE LIBRE SENSOR. CUSTOMER REPORTED VIA SOCIAL MEDIA THAT HE RECEIVED SENSOR READINGS BETWEEN 9-11 MMOL/L (162 - 198 MG/DL) THROUGHOUT THE DAY. IT WAS FURTHER REPORTED THAT CUSTOMER WAS "ILL" AND WAS SEEN IN THE HOSPITAL WHERE A CAPILLARY READING OF 15-16 MMOL/L (270 - 288 MG/DL) WAS OBTAINED COMPARED TO SENSOR READING OF 9 MMOL/L. CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND RECEIVED UNSPECIFIED TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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 ADC FREESTYLE LIBRE SENSOR. CUSTOMER REPORTED VIA SOCIAL MEDIA THAT HE RECEIVED SENSOR READINGS BETWEEN 9-11 MMOL/L (162 - 198 MG/DL) THROUGHOUT THE DAY. IT WAS FURTHER REPORTED THAT CUSTOMER WAS "ILL" AND WAS SEEN IN THE HOSPITAL WHERE A CAPILLARY READING OF 15-16 MMOL/L (270 - 288 MG/DL) WAS OBTAINED COMPARED TO SENSOR READING OF 9 MMOL/L. CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND RECEIVED UNSPECIFIED TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553063 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention