The customer reported that they received erroneous results for one patient sample tested for creatinine plus ver.2 (crep).Results from 2 different c501 analyzers and a c701 analyzer were compared to results from an ortho vitros analyzer.The results from the ortho vitros method were believed to be correct.Given the discordance of the patient's normal biopsy and other normal serum chemistry analysis, the laboratory was contacted about a potential interference and found normal serum creatinine concentrations with the jaffe assay as well as the vitros enzymatic assay.The patient sample was initially tested on c701 analyzer serial number (b)(4)with an unknown reagent lot number, resulting as 2.21 mg/dl.The sample was repeated on c501 analyzer serial number (b)(4) with reagent lot 60387301 (exp: 05/31/2015) on (b)(6) 2014, resulting as 6.31 mg/dl.The 6.31 mg/dl value was reported outside of the laboratory.The sample was manually diluted times 2 and tested on c501 analyzer serial number (b)(4) on (b)(6) 2014, resulting with a raw value of 1.23 mg/dl.The 1.23 mg/dl value was multiplied by the dilution factor, resulting with an actual value of 2.46 mg/dl.The sample was manually diluted times 3 and tested on c501 analyzer serial number (b)(4) on (b)(6) 2014, resulting with a raw value of 0.28 mg/dl.The 0.28 mg/dl value was multiplied by the dilution factor, resulting with an actual value of 0.84 mg/dl.The sample was manually diluted times 3 and tested on c501 analyzer serial number (b)(4) on (b)(6) 2014, resulting with a raw value of 0.28 mg/dl.The 0.28 mg/dl value was multiplied by the dilution factor, resulting with an actual value of 0.84 mg/dl.The sample was manually diluted times 4 and tested on c501 analyzer serial number (b)(4) on (b)(6) 2014, resulting with a raw value of 0.22 mg/dl.The 0.22 mg/dl value was multiplied by the dilution factor, resulting with an actual value of 0.88 mg/dl.The sample was then tested on an ortho vitros analyzer on (b)(6) 2014, resulting as 0.93 mg/dl.The sample was repeated on the ortho vitros analyzer with an on board dilution of times 2 on (b)(6) 2015, resulting as 0.92 mg/dl.The sample was repeated on the ortho vitros analyzer with an on board dilution of times 3 on (b)(6) 2015, resulting as 0.91 mg/dl.The sample was repeated on the ortho vitros analyzer with an on board dilution of times 4 on (b)(6) 2015, resulting as 0.94 mg/dl.The patient was not adversely affected.The customer declined service as he believed the issue to be sample specific.
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