BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S ABD+REV A1,B

    MDR report key: 7676747 · Received July 11, 2018

    Report

    Report Number
    9610824-2018-00040
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 11, 2018
    Report Date
    July 11, 2018
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969951147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH THE HISTORICAL BLOOD GROUP O RH(D) POSITIVE (SAMPLE (B)(6)) WAS TYPED AS B RH(D) NEGATIVE USING ERYTYPE S ABD+REV.A1, B ON TANGO OPTIMO. THE CUSTOMER REPEATED THE SAME SAMPLE (B)(6) ON THE SAME TANGO OPTIMO AND THE PATIENT WAS CORRECTLY TYPED AS O RH(D) POSITIVE. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT ERYTYE S ABD+REV.A1,B FOR INVESTIGATIONAL TESTING BUT THE PATIENT SAMPLE. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1, B WITH THE PATIENT SAMPLE ON TANGO OPTIMO. SAMPLE #051785 YIELDED BLOOD GROUP O RH(D) POSITIVE. THE CORRECTNESS OF THE TYPED BLOOD GROUP OF THE SAMPLE WAS ADDITIONALLY CONFIRMED IN THE GEL CARD METHOD. IN ALL TESTS OF QUALITY CONTROL LABORATORY THE FORWARD AND THE REVERSE TYPING OF THE PATIENT SAMPLE MATCHED. WE DID NOT OBSERVE ANY DISCREPANCIES BETWEEN FORWARD AND REVERSE TYPING. ADDITIONALLY OUR QC LAB'S RETENTION SAMPLE OF ERYTYPE S ABD+REV.A1,B WAS TESTED WITH DIFFERENT DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE RESPECTIVELY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S ABD+REV.A1, B FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS CHECKED BY ONE OF OUR FIELD SERVICE ENGINEERS AND FOUND TO BE RUNNING WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521722 ERYTYPE S ABD+REV A1,B ERYTYPE S ABD+A1,B KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8739110 07611969951147

    Patients

    Seq Age Sex Outcome Treatment
    1