BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA

    MDR report key: 17478034 · Received August 8, 2023

    Report

    Report Number
    3002772505-2023-00001
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    January 4, 2023
    Report Date
    July 17, 2023
    Manufacturer
    DIAGNOSTIC GRIFOLS, S.A.
    Product Code
    KSZ
    PMA / PMN Number
    BK170130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION PROVIDED BY THE CUSTOMER AND THE FIELD SAFETY ENGINEER (FSE) WAS ANALYZED. THE RECOMMENDED BARCODE READER ALIGNMENT AND MIRROR CLEANING, WERE ALREADY PERFORMED BY THE FSE IN THE SERVICE VISIT, ASSURING THAT ALL HARDWARE WAS ALIGNED AND WORKING OPTIMALLY AND NO NEW ISSUES HAVE BEEN REPORTED. IT IS WIDELY RECOGNIZED THAT ISBT CODE 128 HAS BETTER ACCURACY AS A RESULT OF REDUCED MISREADS DURING SCANNING. THIS CODE INCLUDES A CHECKSUM OF THE ENCODED DATA WHICH PROVIDES AN ADDITIONAL PROTECTION. HOWEVER, ALTHOUGH IT IS IMPROBABLE, A MISREAD BARCODE CAN STILL OCCUR. THE PROBABILITY THAT THIS EVENT COULD RESULT IN AN ADVERSE EVENT IS EXTREMELY LOW SINCE, ADDITIONALLY TO THE LOW LIKELIHOOD OF A MISREAD OF THE SAMPLE BARCODE, THE INSTRUMENT WILL NOT BE ABLE TO ASSIGN ANY TEST RECEIVED FROM THE LIS OR MIDDLEWARE TO THE SAMPLE SINCE THE BARCODE WILL NOT MATCH. IN FACT, THE LIS HAS DETECTED THE DISCREPANCY BECAUSE THE WRONG CODE DID NOT CORRESPOND TO A SAMPLE PREVIOUSLY SENT TO THE ANALYZER, PRECLUDING THE POSSIBILITY OF RELEASING THE ASSOCIATED TESTS RESULT TO AN INCORRECT SAMPLE IDENTIFICATION NUMBER. AS PART OF THE IMPROVEMENT PROCESS OF OUR PRODUCTS, IN ERYTRA SOFTWARE VERSION 4.4, THE CONFIGURATION OF THE READER MODULE HAS BEEN MODIFIED IN ORDER TO SET UP A DOUBLE READING CHECK, REDUCING EVEN MORE THE POTENTIAL MISREADING.

    Description of Event or Problem · 0

    ON JULY 17, 2023, THE CUSTOMER REPORTED OBTAINING AN ERRONEOUS BARCODE READING OF A SAMPLE USING ERYTRA SN (B)(6). INSTRUMENT READ Y20020890700640 INSTEAD OF Y20022221701640 ON (B)(6) 2023 AT 10:43 (SAMPLE_DRAWER_4, RACK 1, POSITION 6). THE EVENT WAS DETECTED BY THE LIS BECAUSE THE WRONG CODE DID NOT CORRESPOND TO A SAMPLE PREVIOUSLY SENT TO THE ANALYZER, PRECLUDING THE POSSIBILITY OF RELEASING THE ASSOCIATED TESTS RESULT TO AN INCORRECT SAMPLE IDENTIFICATION NUMBER. THE BARCODE WAS AN ISBT128 WITH CHECKSUM. ON (B)(6) 2023 AT 14:43 THE SAME RACK IS IDENTIFIED AGAIN IN THE INSTRUMENT AND IN THIS OCCASION THE BARCODE WAS CORRECTLY READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772228 ERYTRA AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM KSZ DIAGNOSTIC GRIFOLS, S.A. DG-59

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other