BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2902896 · Received January 9, 2013

    Report

    Report Number
    9610824-2012-00219
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 9, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF THREE PATIENT SAMPLES WITH BIOTESTCELL 3 IN TANGO OPTIMO. THE THREE PATIENT SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS WERE SENT TO US FOR INVESTIGATIONAL TESTING AND THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED, TOO. BUT AT TIME THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT IT WAS ALREADY EXPIRED AND VERY HEMOLYTIC. THEREFORE, A TESTING WAS NOT POSSIBLE. THUS OUR QUALITY CONTROL LABORATORY TESTED THE THREE PATIENT SAMPLES AND POSITIVE AND NEGATIVE CONTROLS WITH THE RETAINED SAMPLE OF BIOTESTCELL 3. THE THREE PATIENT SAMPLES REACTED NEGATIVELY WITH ALL THREE SCREENING CELLS. 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 BIOTESTCELL 3 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. A FIELD SERVICE OF THE AFFECTED TANGO OPTIMO SHOWED THAT ALL RELEVANT RESULT CAMERA IMAGES VALUES ARE IN THE SPECIFIED RANGE. COMPONENTS CRITICAL FOR THE QUALITY OF SOLID SCREEN II APPLICATIONS THAT HAVE AN ADVERSE EFFECT ON RESULT IMAGE APPEARANCE (AIR POCKET) WERE REPLACED AND THE PROBLEM DID NOT REOCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11555 REAGENT RED BLOOD CELLS BIOTESTCELL 3 BIOTESTCELL 3 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8243011

    Patients

    Seq Age Sex Outcome Treatment
    1 AHG, LOT 8221110-02, EXP. 04/20/2014| SOLIDSCREEN II STRIP, LOT 8217050, EXP. 04/20/2014| TANGO OPTIMO, # 9142400457| MLB2, LOT 8220091, EXP. 05/06/2014