D
Patient 1
A CUSTOMER IN THE (B)(6) NOTIFIED BIOM?RIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VIDAS? VARICELLA (IGG) (REFERENCE 30217). THE CUSTOMER REPORTED RUNNING THREE (3) PATIENT SAMPLES USING A NEW LOT OF PRODUCT AND THE RESULTS WERE: 1 NEGATIVE, 1 EQUIVOCAL AND 1 POSITIVE. THE RESULTS FOR SAMPLE NO. (B)(4) DURING THE WEEK OF (B)(6) 2018 ON THE OLD LOT WERE REPORTED AS 3.18. YESTERDAY ((B)(6) 2018) USING NEW LOT THE RESULT WAS 3.92 AND 3.25 WHILE RUNNING THE SAMPLE ON THE OLD LOT. THE RESULTS FOR SAMPLE NO. (B)(4) DURING THE WEEK OF (B)(6) 2018 ON THE OLD LOT WERE REPORTED AS 0.12. YESTERDAY ((B)(6) 2018) USING NEW LOT THE RESULT WAS 0.14 AND 0.13 WHILE RUNNING THE SAMPLE ON THE OLD LOT. THE RESULTS FOR SAMPLE NO. 184027728 DURING THE WEEK OF 26MAR2018 ON THE OLD LOT WERE REPORTED AS 0.80. YESTERDAY (04APR2018) USING NEW LOT THE RESULT WAS 1.05 AND 0.91 WHILE RUNNING THE SAMPLE ON THE OLD LOT. THE CUSTOMER IS CONCERNED WITH RESULTS FOR SAMPLE (B)(4). THE SAMPLE WAS REPORTED LAST WEEK AS AN EQUIVOCAL RESULT WITH A VALUE OF 0.80. YESTERDAY ((B)(6) 2018) ON THE NEW LOT THE RESULTS OBTAINED WERE 1.05. THE CUSTOMER IS CONCERNED THAT EQUIVOCAL RESULTS COULD BE REPORTED AS POSITIVES USING THE NEW LOT WHEN COMPARED TO THE PREVIOUS LOTS. THE CUSTOMER REPORTED THESE DISCREPANT RESULTS LEAD TO A DELAY OF GREATER THAN 24 HOURS. THERE IS NO KNOWN IMPACT TO THE PATIENT DUE TO THE DISCREPANT AND DELAYED RESULTS.