BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

    MDR report key: 2771309 · Received October 4, 2012

    Report

    Report Number
    9610824-2012-00160
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    August 30, 2012
    Report Date
    February 25, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 NEGATIVE REACTION OF A PATIENT SAMPLE WITH BIOTESTCELL 1&2 WHILE TESTING ON TANGO OPTIMO. THE CUSTOMER HAS RETURNED THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT. OUR QUALITY CONTROL LABORATORY IS STILL TESTING THE PATIENT SAMPLE WITH THE RETAINED SAMPLE OF BIOTESTCELL 1&2. THERE IS NO INDICATION FOR A MALFUNCTION OF THE AFFECTED TANGO OPTIMO AND THE CUSTOMER FAILED TO VISUALLY CHECK THE COMPLAINT RESULT IMAGE. WITHOUT VISUAL ASSESMENT OF THE RESULT IMAGES THERE IS NO VALID RESULT OF THE ALLEGEDLY FALSE NEGATIVE REACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE ANTIBODY SCREENING TESTS OF ONE PATIENT. THE CUSTOMER REPORTED THAT AN ANTI-E AND AN ANTI-C WERE MISSED. THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE WAS SENT TO US FOR INVESTIGATIONAL TESTING, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. THEREFORE THE PATIENT SAMPLE WAS TESTED WITH THE RETAINED SAMPLE OF BIOTESTCELL 1&2 AND YIELDED A NEGATIVE RESULT. THE PATIENT SAMPLE WAS ALSO TESTED IN THE TUBE TECHNIQUE. ONLY WHEN APPLYING THE ENZYME TECHNIQUE AND WITH THE ENHANCEMENT MEDIUM POLYETHYLEN GLYCOL (PEG) DID THE PATIENT SAMPLE YIELD A POSITIVE RESULT. THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 1&2 WAS TESTED WITH DIFFERENT SAMPLES AND CONTROLS, E.G. ANTI-E AND ANTI-C. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. THESE TESTS CONFIRM THE ANTIBODIE'S WEAKNESS. REGARDING THE DETECTION OF WEAK ANTIBODIES THERE IS A REFERENCE IN THE INSTRUCTION FOR USE: '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.' TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2 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 AND THE CUSTOMER FAILED TO VISUALLY CHECK THE COMPLAINT RESULT IMAGES. WITHOUT VISUAL ASSESSMENT OF THE RESULT IMAGES THERE IS NO VALID RESULT OF THE ALLEGEDLY FALSE NEGATIVE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL 1&2 BIOTESTCELL 1&2 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8231011

    Patients

    Seq Age Sex Outcome Treatment
    1 ANTI-HUMAN-GLOBULIN, LOT 8142070-03, EXP. 04/24/13| TANGO OPTIMO, # (B)(4)| MLB2, LOT 8209060, EXP. 02/16/2014| SOLIDSCREEN II STRIP, LOT 8202020, EXP. 01/05/2014| MLB2, LOT 8209060, EXP. 02/16/2014| TANGO OPTIMO, # (B)(4)| ANTI-HUMAN-GLOBULIN, LOT 8142070, EXP. 04/24/2013| SOLIDSCREEN II STRIP, LOT 8202020, EXP. 01/05/2014