Description of Event or Problem · 1
THE BLOOD BANK WAS PERFORMING AN ANTIBODY SCREEN ON A PATIENT WITH NO KNOWN RED CELL ANTIBODIES (SAMPLE A) USING AN AUTOMATED INSTRUMENT (BIO-RAD IH-1000 SN (B)(4)). SUBSEQUENTLY, THE ANTIBODY SCREEN WAS FOUND TO BE POSITIVE. AN ADDITIONAL SAMPLE (SAMPLE B) COLLECTED ON THE PATIENT FIVE HOURS AFTER SAMPLE A WAS USED FOR THE ANTIBODY IDENTIFICATION PROCESS, BUT SHOWED NO REACTIVITY. SAMPLE A WAS THEN USED FOR THE IDENTIFICATION PROCESS AND AN ANTI-C WAS IDENTIFIED. AN ANTIBODY SCREEN PERFORMED ON SAMPLE B SHOWED NO REACTIVITY. A THIRD SAMPLE (SAMPLE C) WAS REQUESTED ON THE SAME PATIENT TO RULE OUT A POSSIBLE MISDRAW. SAMPLE C ALSO SHOWED NO REACTIVITY DURING THE ANTIBODY SCREEN. ALL THREE SAMPLES (SAMPLES A, B, C) HAD A BLOOD TYPE OF A NEGATIVE AND AN RH PHENOTYPE OF C-, E-, C+, E+; ALL THREE SAMPLES (SAMPLES A, B, C) WERE CONFIRMED TO BE FROM THE SAME PATIENT. ADDITIONAL INVESTIGATION REVEALED THAT THE ANTIBODY SCREEN PERFORMED ON THE INSTRUMENT WAS PART OF A BATCH WITH TEN OTHER SAMPLES. EIGHT OF THE TEN SAMPLES HAD NEGATIVE ANTIBODY SCREENS, BUT ANOTHER PATIENT (SAMPLE D) A POSITIVE ANTIBODY SCREEN. SAMPLE D HAD A KNOWN HISTORY OF POSITIVE ANTIBODY SCREENS DUE TO ANTI-C, ANTI-E, ANTI-M, ANTI-S. BASED ON OUR OBSERVATION AND PAST HISTORY WITH THE IH-1000 INSTRUMENT WE BELIEVE THAT THE POSITIVE ANTIBODY SCREEN ON SAMPLE A WAS CAUSED BY CONTAMINATION OF SAMPLE A WITH SAMPLE D DUE TO AN INSTRUMENT ERROR. THIS IS OUR THIRD CONFIRMED CASE OF CROSS-CONTAMINATION USING THE IH-1000 INSTRUMENT WHICH IS WHY WE ARE REPORTING IT TO YOU. FDA SAFETY REPORT ID# (B)(4).