BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT SOLIDSCREEN II ANTI-D BLEND

    MDR report key: 5433296 · Received February 12, 2016

    Report

    Report Number
    9610824-2016-00007
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Report Date
    April 20, 2016
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT OF A CONTROL REAGENT WHEN TESTING WITH SOLIDSCREEN II ANTI-D BLEND ON TANGO OPTIMO. THE CUSTOMER USES HEMO BIOSCIENCE QC AS CONTROL REAGENT. DESPITE SEVERAL INQUIRIES, THE CUSTOMER WAS NOT ABLE TO PROVIDE A DATE OF EVENT. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE CONTROL REAGENT THAT HAD CAUSED A FALSE POSITIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF SOLIDSCREEN II ANTI-D BLEND WITH DIFFERENT SAMPLES AND CONTROLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF SOLIDSCREEN II ANTI-D BLEND FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT OF A CONTROL REAGENT WHEN TESTED WITH SOLIDSCREEN II ANTI-D BLEND ON TANGO OPTIMO. THE CUSTOMER USES HEMO BIOSCIENCE QC AS CONTROL REAGENT. THE DATE OF EVENT HAS NOT BEEN PROVIDED YET. THE CUSTOMER ADVISED TO SEND IN THE SUPPOSEDLY DEFECTIVE PRODUCT AND THE CONTROL REAGENT WHICH DID CAUSE A FALSE POSITIVE RESULT FOR INVESTIGATION. WE ARE STILL WAITING FOR THE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92028 BLOOD GROUPING REAGENT SOLIDSCREEN II ANTI-D BLEND SOLIDSCREEN II ANTI-D BLEND KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8519100

    Patients

    Seq Age Sex Outcome Treatment
    1