BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II

    MDR report key: 2512169 · Received April 2, 2012

    Report

    Report Number
    9610824-2012-00044
    Event Type
    Malfunction
    Date Received
    April 2, 2012
    Date of Event
    March 5, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 COMPLAINED A TEST ON TANGO YIELDED A CORRECT POSITIVE ANTIBODY SCREENING BUT A FALSE NEGATIVE IDENTIFICATION. THE CUSTOMER REPORTED THAT THE ANTIBODY WAS IDENTIFIED AS ANTI-K BY USING A COMPETITOR'S PANEL CELLS. THE TANGO OPTIMO IN QUESTION WAS THOROUGHLY INSPECTED. NO INDICATIONS FOR AN INSTRUMENT MALFUNCTION THAT MIGHT BE CAUSATIVE FOR THIS EVENT WERE FOUND. THE PATIENT SAMPLE THAT HAD CAUSED FALSE NEGATIVE RESULTS WAS SENT TO US FOR QUALITY CONTROL, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II WITH DIFFERENT ANTIBODIES, INCLUSIVE AN ANTI-K. 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 ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II 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 NEGATIVE ANTIBODY IDENTIFICATION TEST ON TANGO OPTIMO. THE CUSTOMER REPORTED THAT AN ANTIBODY SCREENING TEST WAS POSITIVE, BUT IN IDENTIFICATION TEST HE MISSED AN ANTI-K. THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT WAS SENT TO US FOR INVESTIGATIONAL TESTING, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT HAS BEEN RETURNED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE RETAINED SAMPLE OF ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II AND SCREENING CELLS. THE K POSITIVE SCREENING CELL REACTED WEAKLY POSITIVE. THE PATIENT SAMPLE WAS ALSO TESTED WITH IDENTIFICATION PANEL CELLS. ALL K POSITIVE CELLS REACTED NEGATIVELY. FURTHERMORE THE PATIENT SAMPLE WAS TESTED IN THE GEL METHOD AND REACTED NEGATIVELY. THE PATIENT SAMPLE REACTED POSITIVELY ONLY WITH THE ENHANCEMENT MEDIUM POLYETHYLENE-GLYCOL (PEG). THEREFORE WE STRONGLY ASSUME THE EXISTENCE OF AN WEAK REACTING ANTIBODY. IN THE INSTRUCTION FOR USE THERE IS AN HINT UNDER LIMITATIONS: 'NEGATIVE REACTIONS WILL BE OBTAINED IF THE SAMPLE CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHOD EMPLOYED. NO TEST METHOD IS CAPABLE OF DETECTING ALL RED CELL ANTIBODIES.' FURTHERMORE OUR QUALITY CONTROL LABORATORY TESTED THE ALLEGEDLY DEFECTIVE PRODUCT WITH DIFFERENT ANTIBODIES, INCLUSIVE AN ANTI-K. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II 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 TANGO OPTIMO IN QUESTION WAS THOROUGHLY INSPECTED. NO INDICATION FOR AN INSTRUMENT MALFUNCTION THAT MIGHT BE CAUSATIVE FOR THIS EVENT HAS BEEN FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II AHG ANTI-IGG SOLIDSCREEN II KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOTESTCELL 3, LOT 8203011, EXP. 03/06/2012| MLB2, LOT 8114021, EXP. 03/25/2013| MLB2, LOT 8114021, EXP. 03/25/2013| BIOTESTCELL I11 PANEL, LOT 8205011, EXP. 03/20/12| SOLIDSCREEN STRIP, LOT 8142020, EXP. 10/13/2013| BIOTESTCELL I11 PANEL, LOT 8205011, EXP. 03/20/12| SOLIDSCREEN STRIP, LOT 8142020, EXP. 10/13/2013| BIOTESTCELL 3, LOT 8203011, EXP. 03/06/2012| TANGO OPTIMO, SERIAL NO. 9142400391| TANGO OPTIMO, SERIAL NO. 9142400391