BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA

    MDR report key: 10117514 · Received June 4, 2020

    Report

    Report Number
    3002772505-2020-00001
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    May 3, 2020
    Report Date
    May 4, 2020
    Manufacturer
    DIAGNOSTIC GRIFOLS, S.A
    Product Code
    KSZ
    UDI-DI
    08437014205190
    PMA / PMN Number
    BK170130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION PROVIDED BY THE CUSTOMER AND THE FIELD SAFETY ENGINEER (FSE) WAS ANALYZED. THE LABEL WITH THE BARCODE HAS BEEN VERIFIED AND PROVIDED AN OVERALL GRADE A, MEANING THAT THE DIFFERENT PARAMETERS OF THE BARCODE (DECODABILITY, SYMBOL CONTRAST, REFLECTION, EDGE CONTRAST , MODULATION AND DEFECTS) ARE CORRECT. THE LOGFILES REVEALED A HIGH NUMBER OF RETRIES TO READ THE BARCODES IN THIS SPECIFIC INSTRUMENT, SO IT SEEMS THAT SOME MISALIGNMENT COULD CAUSE THE MISREADING. IF THE READING WINDOW IS NOT CENTERED IN THE SAMPLES RACK READING APERTURE, THE MISREAD COULD TAKE PLACE IN THE EXTREME OF THAT READING APERTURE, SO SOME GLARING (OR ANY OTHER OPTICAL EFFECT) COULD HAVE AFFECTED THE BC READER GENERATING THE MISREADING. THESE MISALIGNMENTS ARE VERY RARE TO OCCUR, AND THEY CAN BE CAUSED DUE TO A HIT. HOWEVER, IT CANNOT BE DISCARDED THAT DURING THE BARCODE READING, SOME CONDENSED WATER DROPS OR DUST PARTICLES COULD INTERFERE WITH THE LASER BEAM. 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. NO NEW ISSUES ARE 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 ADDITION, THE LIS WOULD ALSO DETECT THE DISCREPANCY BECAUSE THE MISREAD CODE EITHER WOULD NOT EXIST OR WOULD NOT CORRESPOND TO A SAMPLE PREVIOUSLY SENT TO THE ANALYZER. THE INVESTIGATION CONFIRMED A LOW LIKELIHOOD OF THIS ISSUE. IT IS ALSO SUPPORTED BY THE FACT THAT IT IS THE FIRST AND ONLY TIME THE DEVICE HAS MISREAD A BARCODE NUMBER. HOWEVER, AS PART OF THE IMPROVEMENT PROCESS OF OUR PRODUCTS, THE CONFIGURATION OF THE READER MODULE WILL BE MODIFIED IN A FUTURE SOFTWARE VERSION IN ORDER TO SET UP A DOUBLE READING CHECK , REDUCING EVEN MORE THE POTENTIAL MISREADING.

    Description of Event or Problem · 0

    ON (B)(6) 2020, THE CUSTOMER (B)(6), REPORTED TO GRIFOLS A SAMPLE BARCODE READING ERROR OCCURRED DURING THE VALIDATION/CORRELATION OF A CROSSMATCH TEST. THE ERYTRA FULLY AUTOMATED IMMUNOHEMATOLOGY ANALYZER READ THE DONOR SAMPLE BARCODE AS (B)(6) INSTEAD OF THE EXPECTED NUMBER (B)(6). THE EVENT WAS DETECTED BY THE OPERATOR WHEN CHECKING THE BARCODES TO REPEAT THE CROSSMATCH TESTS MANUALLY. THE SAME BARCODE WAS LATER READ AGAIN WITH THE SAME INSTRUMENT AND WITH ANOTHER ERYTRA ANALYZER, AND THE BARCODE WAS READ CORRECTLY. THE CUSTOMER CONFIRMS THAT THIS WAS THE FIRST AND ONLY TIME THE DEVICE HAS MISREAD A BARCODE NUMBER. THE BARCODE WAS AN ISBT128 WITH CHECKSUM FROM A DONOR'S BAG FROM THE RED CROSS UNIT. NOTE THAT WHEN THE CUSTOMER IS WORKING IN ROUTINE CONDITIONS, THE INSTRUMENT IS INTERFACED WITH THE LIS. THE LIS WOULD DETECT THE DISCREPANCY BECAUSE THE WRONG CODE EITHER WOULD NOT EXIST OR WOULD 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY THE CUSTOMER AND THE FIELD SERVICE ENGINEER (FSE) ARE CURRENTLY UNDER STUDY. THE FSE ENSURED THAT THE BARCODE READER MIRRORS WERE CLEAN AND THAT BARCODE READERS WERE ALIGNED. ALL HARDWARE WAS CORRECTLY ALIGNED AND WORKING OPTIMALLY. THE LABEL WITH THE BARCODE HAS BEEN VERIFIED AND PROVIDED AN OVERALL GRADE A, MEANING THAT THE DIFFERENT PARAMETERS OF THE BARCODE (DECODABILITY, SYMBOL CONTRAST, REFLECTION, EDGE CONTRAST, MODULATION AND DEFECTS) ARE CORRECT. HOWEVER, IT CANNOT BE DISCARDED THAT DURING THE BARCODE READING, SOME CONDENSED WATER DROP OR DUST PARTICLE COULD INTERFERE WITH THE LASER BEAM. 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. IT IS NOTED THAT IT IS THE FIRST AND ONLY TIME THE DEVICE HAS MISREAD A BARCODE NUMBER. THE CASE IS STILL UNDER INVESTIGATION. THIS REPORT WILL BE UPDATED ONCE IT IS CONCLUDED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE CUSTOMER (B)(6) , REPORTED TO GRIFOLS A SAMPLE BARCODE READING ERROR OCCURRED DURING THE VALIDATION/CORRELATION OF A CROSSMATCH TEST. THE ERYTRA FULLY AUTOMATED IMMUNOHEMATOLOGY ANALYZER READ THE DONOR SAMPLE BARCODE AS (B)(6) INSTEAD OF THE EXPECTED NUMBER (B)(6). THE EVENT WAS DETECTED BY THE OPERATOR WHEN CHECKING THE BARCODES TO REPEAT THE CROSSMATCH TESTS MANUALLY. THE SAME BARCODE WAS LATER READ AGAIN WITH THE SAME INSTRUMENT AND WITH ANOTHER ERYTRA ANALYZER, AND THE BARCODE WAS READ CORRECTLY. THE CUSTOMER CONFIRMS THAT THIS WAS THE FIRST AND ONLY TIME THE DEVICE HAS MISREAD A BARCODE NUMBER. THE BARCODE WAS AN ISBT128 WITH CHECKSUM FROM A DONOR'S BAG FROM THE RED CROSS UNIT. NOTE THAT WHEN THE CUSTOMER IS WORKING IN ROUTINE CONDITIONS, THE INSTRUMENT IS INTERFACED WITH THE LIS. THE LIS WOULD DETECT THE DISCREPANCY BECAUSE THE WRONG CODE EITHER WOULD NOT EXIST OR WOULD 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585450 ERYTRA AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEM KSZ DIAGNOSTIC GRIFOLS, S.A DG-59 08437014205190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other