BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTESTCELL 3

    MDR report key: 3842423 · Received June 2, 2014

    Report

    Report Number
    9610824-2014-00044
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 24, 2014
    Report Date
    March 2, 2015
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE MISSED AN ANTIBODY WHEN TESTING WITH BIOTESTCELL 3 ON TANGO OPTIMO. THE ANTIBODY NOT DETECTED CAUSED A HEMOLYTIC TRANSFUSION REACTION. THE CUSTOMER REPORTED THAT IN THE SAMPLE DRAWN BEFORE TRANSFUSION AN ANTI-C COULD BE IDENTIFIED. IN A PATIENT SAMPLE DRAWN AFTER THE TRANSFUSION ADDITIONALLY AN ANTI-JK(B) COULD BE IDENTIFIED. THE CUSTOMER DID RETURN TWO PATIENT SAMPLES ((B)(6)) THAT WERE DRAWN AFTER THE TRANSFUSION, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 3. THE RED BLOOD CELLS HAD BEEN SEPARATED FROM THE PLASMA. THE CUSTOMER DID NOT RETURN THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. UPON RECEIPT OF THE PATIENT SAMPLES, THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 3 WAS ALREADY EXPIRED. IN SPITE OF THIS FACT THE PATIENT SAMPLES WERE TESTED WITH THE EXPIRED LOT OF BIOTESTCELL 3 AND THE CURRENT LOT OF BIOTESTCELL 3. BOTH SAMPLES WERE TESTED ON TANGO OPTIMO WITH OUR QUALITY CONTROL LABORATORY'S RETAINED BIOTESTCELL 3 LOT 8412011-00 SAMPLE, THE ALLEGEDLY DEFECTIVE LOT THAT HAD ALREADY EXPIRED. ONLY REAGENT RED BLOOD CELL #1 (C POS., JKA-B+) YIELDED POSITIVE RESULTS. (B)(4)). THE SAMPLES WERE ALSO TESTED WITH BIOTESTCELL 3 LOT 8420011-00. REAGENT RED BLOOD CELL #1 (C POS. JKB NEG.) REACTED WITH BOTH SAMPLES CLEARLY POSITIVE (3W, 3+). SAMPLE 052014 ALSO SHOWED A +/- REACTION WITH RED BLOOD CELL #2 (JKA- B+). ADDITIONAL IDENTIFICATION TESTING DID NOT YIELD AN ANTIBODY RESULT. SAMPLE ID (B)(4) REACTED ONLY WITH I3 (C POS., JKA+B-) AND I11 (C POS., JKA-B+) OF BIOTESCELL I11. SAMPLE ID (B)(4) WITH I1(C POS., JKA+B-) AND I3 (C POS., JKA+B-). THE REACTION STRENGTHS WERE +/- TILL 1+. FURTHER TESTING IN GEL (LISS/COOMBS) WITH BIOTESTCELL 3 AND ID-DIACELL I-II-III YIELDED WITH THE CORRESPONDING RED BLOOD CELLS NEGATIVE TILL 2W REACTIONS. ONLY IN TUBE WITH THE ENHANCEMENT POLYETHYLENE GLYCOL (PEG) THE PROVIDED PATIENT SAMPLES REACTED WITH THE CORRESPONDING REAGENT RED BLOOD CELLS CORRECTLY POSITIVE WITH ALL CELLS HAVING THE CORRESPONDING ANTIGEN. THE TEST RESULTS STRONGLY SUGGEST THAT BOTH ANTIBODIES ARE WEAK REACTING ANTIBODIES, ESPECIALLY THE ANTI-JK(B). THE INSTRUCTION FOR USE CONTAIN AN APPROPRIATE HINT: 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. THE SUPPOSEDLY DEFECTIVE PRODUCT BIOTESTCELL 3 WAS TESTED WITH DIFFERENT KNOWN ANTIBODIES, AMONGST OTHERS ANTI-C AND ANTI-JKB. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT 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. THE AFFECTED TANGO OPTIMO WENT THROUGH SCHEDULED PREVENTIVE MAINTENANCE ON APRIL 23, 2014 WITH NO ISSUES. THE VERY SAME TANGO OPTIMO WAS MOST THOROUGHLY INSPECTED BY TWO FIELD SERVICE ENGINEERS ON MAY 12, 2014 WITH NOT THE SLIGHTEST INDICATION FOR ANY PERFORMANCE ISSUES. FOUR SAMPLE WERE TESTED IN A SERIAL DILUTION OF UP TO 1:32 ON INSTRUMENT IN QUESTION WITH NO SENSITIVITY ISSUES. THERE IS NO INDICATION FOR A MALFUNCTION OF THE AFFECTED TANGO OPTIMO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE MISSED AN ANTIBODY WHEN TESTING WITH BIOTESTCELL 3 ON TANGO OPTIMO. THE ANTIBODY NOT DETECTED CAUSED A HEMOLYTIC TRANSFUSION REACTION. THE CUSTOMER HAS RETURNED THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE RESULT, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT. TESTING OF THE RETAINED BIOTESTCELL 3 SAMPLE IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WENT THROUGH SCHEDULED PREVENTIVE MAINTENANCE ON (B)(6) 2014 WITH NO ISSUES. THE VERY SAME TANGO OPTIMO WAS MOST THOROUGHLY INSPECTED BY TWO FIELD SERVICE ENGINEERS ON (B)(6) 2014 WITH NOT THE SLIGHTEST INDICATION FOR ANY PERFORMANCE ISSUES. FOUR SAMPLE WERE TESTED IN A SERIAL DILUTION OF UP TO 1:32 ON INSTRUMENT IN QUESTION WITH NO SENSITIVITY ISSUES. THERE IS NO INDICATION FOR A MALFUNCTION OF THE AFFECTED TANGO OPTIMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321049 BIOTESTCELL 3 BIOTESTCELL 3 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8412011-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AHG, LOT 8343150-02, EXP. 2015-04-18| TANGO OPTIMO, # (B)(4)| MLB2, LOT 8334090-00| SOLIDSCREEN II STRIP, LOT 8324050