BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S ABD+REV A1,B

    MDR report key: 11364515 · Received February 23, 2021

    Report

    Report Number
    9610824-2021-00003
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    February 6, 2021
    Report Date
    February 23, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHR
    UDI-DI
    07611969951147
    PMA / PMN Number
    125094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILED PATIENT BLOOD GROUPS WHEN USING ERYPECE S ABD+REV A1,B ON TANGO OPTIMO, BECAUSE THERE WAS A "GOB" IN THE REVERSE A1 CELLS WHICH THE TANGO INTERPRETED AS POSITIVE. HE CONFIRMED THAT THE TANGO OPTIMO IS FUNCTIONING PROPERLY. THE CUSTOMER MENTIONED THAT HE RECEIVED THE AFFECTED PRODUCT IN BOXES THAT WERE DAMAGED AND THE PLATES HE RECEIVED WERE WET. THESE CONDITIONS SHOULD NOT HAVE A NEGATIVE IMPACT TO THE QUALITY OF THE ERYTYPE PLATES, BECAUSE THEY ARE SEALED IN A SPECIAL ALUMINUM FOIL WHICH IS IMPERMEABLE TO WATER VAPOR. A NEGATIVE IMPACT CANNOT BE EXCLUDED IN CASE THE SEALING OF THE PLATES WAS DAMAGED. IN ORDER TO EXCLUDE A DAMAGING OF THE SEALING THE CUSTOMER WAS ENCOURAGED TO RETURN THE PLATES FOR INVESTIGATION. THE CUSTOMER DID NOT PROVIDE THE AFFECTED PLATES FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ERYTYPE S ABD+REV.A1, B WITH DIFFERENT DONOR SAMPLES ON TANGO OPTIMO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT SEE ANY CLUMPS IN THE REVERSE TYPING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261711 ERYTYPE S ABD+REV A1,B ERYTYPE S ABD+REV A1,B QHR BIO-RAD MEDICAL DIAGNOSTICS GMBH 8045010 07611969951147

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO OPTIMO, SN (B)(4)