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The customer stated that their phosphate (inorganic) ver.2 - phos controls were high on (b)(6) 2016 on the c501 analyzer.The customer then recalibrated the assay and controls were within range after this.On the morning of (b)(6) 2016, controls were low.The customer then replaced the reagent cassette and repeated controls.The controls recovered within range.The customer tried running controls on the old cassette, but these were still low.The customer then calibrated the old cassette and repeated controls.The controls recovered within range.The customer later stated that phos results were questioned for a total of 10 patient samples.Of the 10 samples, four had initial erroneous results that were reported outside of the laboratory.The customer stated that the samples were initially repeated on a different c501 analyzer, but they then repeated the samples on the original c501 analyzer using the new reagent pack.The customer was asked, but could not specify which analyzer was used for each provided repeat result.The customer states that the samples were repeated on both c501 analyzers and repeat results were identical for each.The repeat results were believed to be correct and corrected reports were issued.The first sample initially resulted as 1.3 mg/dl.The sample was repeated, resulting as 2.3 mg/dl.The second sample, from a (b)(6) female, initially resulted as 2.1 mg/dl.The sample was repeated, resulting as 3.1 mg/dl.The third sample, from a (b)(6) male, initially resulted as 2.9 mg/dl.The sample was repeated, resulting as 3.9 mg/dl.The fourth sample, from a (b)(6) male, initially resulted as 1.5 mg/dl.The sample was repeated, resulting as 2.6 mg/dl.It was asked, but it is not known if the patients were adversely affected.No adverse events were alleged.The phos reagent lot number was 61756001, with an expiration date of 11/30/2016.The field service representative determined that there was a fluidics failure of the rinse mechanism.He stated that the line going to the rinse mechanism was clogged, causing restriction of the correct dispensation of rinse levels.He cleaned and flushed the line with bleach and deionized water.He adjusted the rinse levels to specification.He ran precision studies and results were within specification.The customer successfully ran quality controls.An issue with either the reagent or pre-analytic sample handling can be excluded based on investigation findings.
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