BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 16942998 · Received May 16, 2023

    Report

    Report Number
    2954323-2023-19376
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    April 1, 2023
    Report Date
    June 16, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. A VALID SERIAL NUMBER WAS NOT PROVIDED FOR THE STRIPS. DHRS (DEVICE HISTORY RECORD) FOR THE FREESTYLE FREEDOM LITE METER WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE FREEDOM LITE METER PASSED ALL TESTS PRIOR TO RELEASE. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT PRECISION STRIPS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR PRECISION STRIPS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD HAVE LED TO THE COMPLAINT. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND PRECISION STRIPS. NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. THE REPORTED METER HAVE BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED ON THE METER AND NO ISSUES WERE OBSERVED. METER POWERED ON WITH BUTTON AND RETAINED TEST STRIPS. CONTROL SOLUTION TESTING HAS BEEN PERFORMED AND ALL RESULTS WERE WITHIN RANGE SPECIFICATION. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. IF THE PARTIAL PRODUCT 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.UPON EXTENDED INVESTIGATION, IT WAS DETERMINED THAT THE LOT NUMBER PROVIDED BY THE CUSTOMER (1192738) AND PREVIOUSLY REPORTED TO THE FDA WAS NOT A VALID LOT NUMBER.  THEREFORE, SECTION D4 WAS UPDATED TO UNK.

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. 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.

    Description of Event or Problem · 0

    AN ERRONEOUS READINGS ISSUE WAS REPORTED WITH USE OF THE ADC DEVICE. CUSTOMER RECEIVED LOWER THAN FEELS SCANS AND EXPERIENCED TIREDNESS. CUSTOMER WAS UNABLE TO SELF-TREAT AND WAS TREATED WITH AN UNSPECIFIED INJECTION, ACTS 30MG, GLIMEPIRIDE 4MG, VOCANAMET 150MG-1000MG, AND INSULIN TOUJEO BY A HCP. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    AN ERRONEOUS READINGS ISSUE WAS REPORTED WITH USE OF THE ADC DEVICE. CUSTOMER RECEIVED LOWER THAN FEELS SCANS AND EXPERIENCED TIREDNESS. CUSTOMER WAS UNABLE TO SELF-TREAT AND WAS TREATED WITH AN UNSPECIFIED INJECTION, ACTS 30MG, GLIMEPIRIDE 4MG, VOCANAMET 150MG-1000MG, AND INSULIN TOUJEO BY A HCP. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705892 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 70914-70 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention