BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CREATININE

    MDR report key: 6955860 · Received October 17, 2017

    Report

    Report Number
    1628664-2017-00382
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Report Date
    October 17, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CGX
    UDI-DI
    00380740005993
    PMA / PMN Number
    K981799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, LABELING REVIEW, AND MANUFACTURING REVIEW. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. MANUFACTURING REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. HOWEVER, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED. THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1415939-2017-00130 UNDER A DIFFERENT SUSPECT DEVICE MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS GENERATED USING THE ARCHITECT CLINICAL CHEMISTRY CREATININE REAGENTS. THE FOLLOWING DATA WAS PROVIDED (MG/DL). (B)(6) (TESTED IN (B)(6) 2016) INITIAL 2.1, RETEST 1.5, 1.5. ADDITIONAL UNOPENED SPECIMEN RETEST 0.9, 0.9. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736592 CLINICAL CHEMISTRY CREATININE CREATININE CGX ABBOTT MANUFACTURING INC 36678UN15 00380740005993

    Patients

    Seq Age Sex Outcome Treatment
    1