BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 14402764 · Received May 13, 2022

    Report

    Report Number
    2954323-2022-15564
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    May 1, 2022
    Report Date
    July 1, 2022
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLG
    PMA / PMN Number
    VERIFY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR KIT WAS REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01 WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01 ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR KIT WAS REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01 WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01 ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.THIS SERVES AS A CORRECTION REPORT: IT WAS DETERMINED THE CUSTOMER HAD INITIALLY REPORTED THE SAME ADVERSE EVENT AS REPORTED IN THIS SUBMISSION TO ADC VIA A WEBFORM ON 5-MAY-2022. AS SUCH, ABBOTT DIABETES CARE (ADC) CONSIDERS 5-MAY-2022 TO BE THE MANUFACTURER'S AWARENESS DATE. THERE WAS NO ADDITIONAL INFORMATION REGARDING THE ADVERSE EVENT PROVIDED.

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION WAS PERFORMED AND NO ISSUES WERE OBSERVED ON SENSOR PATCH. ADHESIVE WAS NOT RETURNED. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. IF THE ADHESIVE IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE ADC DEVICE DETACHED PREMATURELY ON THE 10TH DAY OF WEAR AND THEREFORE, THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. THE CUSTOMER BECAME HYPOGLYCEMIC AND EXPERIENCED A SEIZURE AND LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND RECEIVED UNSPECIFIED MEDICAL TREATMENT BY A THIRD PARTY. NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE ADC DEVICE DETACHED PREMATURELY ON THE 10TH DAY OF WEAR AND THEREFORE, THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. THE CUSTOMER BECAME HYPOGLYCEMIC AND EXPERIENCED A SEIZURE AND LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND RECEIVED UNSPECIFIED MEDICAL TREATMENT BY A THIRD PARTY. NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE ADC DEVICE DETACHED PREMATURELY ON THE 10TH DAY OF WEAR AND THEREFORE, THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. THE CUSTOMER BECAME HYPOGLYCEMIC AND EXPERIENCED A SEIZURE AND LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND RECEIVED UNSPECIFIED MEDICAL TREATMENT BY A THIRD PARTY. NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039975 FREESTYLE LIBRE 3 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE LTD 72114-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention