BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-100 HBA1C, D-100¿ HBA1C CALIBRATOR PACK

    MDR report key: 6579958 · Received May 19, 2017

    Report

    Report Number
    2915274-2017-00010
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    March 21, 2017
    Report Date
    April 10, 2017
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    PDJ
    UDI-DI
    00847817015953
    PMA / PMN Number
    K151321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION THE LIKELY CAUSE OF THE ISSUE IS ATTRIBUTED TO AN LIS PROGRAMMING, A NON-BIO-RAD PRODUCT. THERE WAS NO EVIDENCE OF MALFUNCTION ON THE D-100 SYSTEM AND THE SYSTEM WAS PERFORMING PER THE MANUFACTURER'S SPECIFICATION AT THE TIME OF INCIDENT. THE CUSTOMER DISCOVERED THAT THE A1C RESULT RECORDED IN THE D-100¿ SYSTEM DATABASE, FOR THIS SAMPLE, WAS 5.5 % (CORRECT), NOT 11.2%. THE CUSTOMER ALSO EVALUATED THE ASTM FILES AND FOUND THAT THE RESULT SENT TO THE LIS WAS ALSO 5.5%, NOT 11.2%. IFCC AND EAG VALUES WERE ALSO SENT, BUT ONLY THE NGSP CHANGED ERRONEOUSLY AT THE LIS SYSTEM. THE CUSTOMER USES ONE LIS PROGRAM FOR THREE DIFFERENT SYSTEMS (TWO VARIANT¿ II TURBO SYSTEMS (PLUS ONE PC) AND ONE D-100¿ SYSTEM). ALTHOUGH THE LIS VENDOR WAS NOT ABLE TO LOCATE THE RAW DATA FOR THIS ONE SAMPLE, IT WAS NOTED THAT THE CUSTOMER HAD CORRECTED AN UNKNOWN SAMPLE ID (I.E. AN UNREAD BARCODE) SENT BY THE VARIANT¿ II TURBO SYSTEM AT THE LIS. A SAMPLE RESULT WITH AN UNKNOWN SAMPLE ID (I.E. UNREAD BARCODE) CAN OVERWRITE A CORRECTLY-READ BARCODE SAMPLE ID IF IT HAD BEEN TRANSFERRED TO LIS AT THE SAME TIME. THE CUSTOMER WAS SUGGEST TO MAKE EDITS OF UNREAD BARCODES ON THE BIO-RAD SYSTEM AND NOT AT THE LIS TO AVOID OVERWRITING. THE CUSTOMER WAS ALSO SUGGESTED TO SEPARATE THE LIS PC FROM THE D-100¿ SYSTEM AND VARIANT¿ II TURBO PC. ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER DUE PATIENT CONFIDENTIALITY. NO FURTHER INCIDENT INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. BIO-RAD CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE. (MAY 4, 2017)

    Description of Event or Problem · 1

    THE PHYSICIAN TREATED THE PATIENT BASED ON THE INCORRECT RESULT, 11.2% HBA1C THAT APPEARS TO CAUSED PATIENT HARM. THE D-100 HEMOGLOBIN TESTING SYSTEM DATABASE REVIEW SHOWS THAT THE SYSTEM CORRECTLY TRANSMITTED A 5.5% HBA1C, NGSP VALUE TO LIS. THE CHANGE TO THE PATIENT'S HBA1C VALUE OCCURED OUTSIDE OF THE CUSTODY OF THE D-100 HEMOGLOBIN TESTING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359971 D-100 HBA1C, D-100¿ HBA1C CALIBRATOR PACK GLYCOSYLATED HEMOGLOBIN ASSAY PDJ BIO-RAD LABORATORIES, INC. 290-1004 00847817015953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other