BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREC XTRA B-KET-NO CODING

    MDR report key: 17007482 · Received May 25, 2023

    Report

    Report Number
    2954323-2023-21783
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    April 24, 2023
    Report Date
    May 25, 2023
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K040814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT WERE REVIEWED FOR XTRA METER 3 BUTTON PRECISION AND PORT-2 FOR THE LAST YEAR. THE REVIEW DID NOT IDENTIFY ANY TRENDS THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES RELATED TO THIS COMPLAINT.. IF THE 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.

    Description of Event or Problem · 0

    CUSTOMER REPORTED BEING UNABLE TO TEST DUE TO HIS ADC BLOOD GLUCOSE METER TURNING ON WITH BUTTON PRESS BUT NOT WITH TEST STRIP INSERTION. AS A RESULT, THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND/OR CONVULSION/SEIZURE. THERE WAS NO REPORT OF THE CUSTOMER RECEIVING TREATMENT BY HCP OR THIRD-PARTY. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650744 PREC XTRA B-KET-NO CODING BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 98814-65 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other