BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT SOLIDSCREEN II ANTI-D BLEND

    MDR report key: 3110497 · Received May 14, 2013

    Report

    Report Number
    9610824-2013-00049
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF A SINGLE PATIENT SAMPLE WITH SOLIDSCREEN II ANTI-D BLEND ON TANGO OPTIMO. THE CUSTOMER HAS NEITHER RETURNED THE SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT NOR THE SUPPOSEDLY DEFECTIVE PRODUCT. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SOLIDSCREEN II ANTI-D BLEND SAMPLE WITH DIFFERENT DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED 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 REACTION OF A SINGLE PATIENT SAMPLE WITH SOLIDSCREEN II ANTI-D BLEND ON TANGO OPTIMO. THE CUSTOMER HAS NEITHER RETURNED THE SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT NOR THE SUPPOSEDLY DEFECTIVE PRODUCT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SOLIDSCREEN II ANTI-D BLEND SAMPLE WITH DIFFERENT DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED 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. THERE IS NO INDICATION FOR A MALFUNCTION OF THE AFFECTED TANGO OPTIMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213407 BLOOD GROUPING REAGENT SOLIDSCREEN II ANTI-D BLEND SOLIDSCREEN II ANTI-D BLEND KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8145190-01

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO OPTIMO, # 9142400403| SOLIDSCREEN II STRIP, LOT 8236120, EXP. 08/31/2014| MLB2, LOT 8229120, EXP. 08/07/2014| ALSEVERS, LOT 8246011, EXP. 09/26/2014| TANGO OPTIMO, # 9142400404| SOLIDSCREEN II STRIP, LOT 8236120, EXP. 08/31/2014| AHG, LOT 8231160-04, EXP. 01/25/2014| TANGO OPTIMO, # 9142400404| ALSEVERS, LOT 8246011, EXP. 09/26/2014| AHG, LOT 8231160-04, EXP. 01/25/2014| MLB2, LOT 8229120, EXP. 08/07/2014| TANGO OPTIMO, # 9142400403