BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL I11 PLUS

    MDR report key: 3003313 · Received March 14, 2013

    Report

    Report Number
    9610824-2013-00023
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 14, 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 COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF ONE PATIENT WITH CELLS OF BIOTESTCELL-I11 PLUS WHEN TESTING ON TANGO OPTIMO. THE CUSTOMER REPORTED A CLEAR ANTI-LE(A) PATTERN OF THE PATIENT SAMPLE IN THE TUBE TEST WITH THE ENHANCEMENT MEDIUM POLYETHYLEN GLYCOL (PEG). THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT WAS SENT TO US FOR INVESTIGATIONAL TESTING AND THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED, TOO. BUT SINCE THE VIAL CONTAINING THE SUPPOSEDLY DEFECTIVE PRODUCT WAS NOT CLOSED PROPERLY, IT HAD BEEN LEAKED UPON ARRIVAL IN OUR QUALITY CONTROL LABORATORY. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE RETAINED BIOTESTCELL I-11 PLUS SAMPLE. CELL #1, #2, #4,#5,#6, #7 AND #9 SHOWED A WEAK POSITIVE REACTION, WHILE CELL #3, #8, #10 AND #11 SHOWED NEGATIVE REACTIONS. THE PATIENT SAMPLE WAS ALSO TESTED IN THE 3-PHASE TUBE TECHNIQUE AND SHOWED WEAK POSITIVE REACTIONS WITH ALL THREE SCREENING CELLS. ADDITIONALLY, THE PATIENT SAMPLE WAS TESTED IN THE ENZYM TECHNIQUE AS WELL AS IN TUBE WITH AN INCUBATION AT COLD. IN BOTH METHODS THE PATIENT SAMPLE ALSO YIELDED POSITIVE REACTIONS WITH ALL THREE SCREENING CELLS, AND NOT ONLY WITH THE LE(A) POSITIVE SCREENING CELL. THE PATIENT SAMPLE WAS ALSO TESTED WITH THE ENHANCEMENT MEDIUM POLYETHYLEN GLYCOL IN TUBE TECHNIQUE. IN THIS METHOD ONLY THE LE(A) POSITIVE SCREENING CELL REACTED POSITIVELY. OUR TESTINGS STRONGLY SUGGEST THAT THERE IS AT LEAST ONE MORE ANTIBODY BESIDES THE ASSUMED ANTI-LE(A). OUR RETAINED BIOTESTCELL I-11 PLUS SAMPLE WAS TESTED WITH FURTHER CONTROLS AND SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS, ONLY OCCASIONALLY A HAZE SURROUNDING OF THE CELL BUTTON. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11 PLUS FUNCTIONS CORRECTLY.A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. REGARDING THE AFFECTED TANGO OPTIMO, A FIELD SERVICE ENGINEER REPORTED A POSSIBLE CONTAMINATION OF THE LIQUID SYSTEM AND REPLACED THE VAST MAJORITY OF THE INBOUND LIQUID SYSTEM. HOWEVER, AN INSTRUMENT RELATED PROBLEM SEEMS RATHER UNLIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107663 REAGENT RED BLOOD CELLS BIOTESTCELL I11 PLUS BIOTESTCELL I11 PLUS KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8303011-00

    Patients

    Seq Age Sex Outcome Treatment
    1 MLB2, LOT 8209SS60| AHG, LOT 8221110-05, EXP. 11/14/2013| TANGO OPTIMO, # (B)(4)