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The customer reported that they had questionable results for approximately 47 patient samples tested for tina-quant hemoglobin a1cdx gen.2 (hba1c).Of these samples, twenty three had erroneous results that were reported outside of the laboratory.The customer first noticed that their closing control recovery was high.The customer then performed a calibration and repeated controls.Controls were within range, so they resumed operation.The customer then noticed that they received flagged results for ten patient samples and approximately 5 additional patient samples had results that appeared to be abnormally low.After noticing the abnormal results, the customer stopped the instrument and performed several checks of the instrument.The checks passed.The customer also changed the sample probes and repeated controls.Controls were not acceptable.The customer later repeated additional patient samples on a different integra analyzer.It was determined that 23 patient samples had initial erroneous results that were reported outside of the laboratory.The repeat results from the other integra analyzer were believed to be correct and corrected reports were issued.The first sample initially resulted as 6.93 % and repeated as 5.23 %.The second sample initially resulted as 7.28 % and repeated as 5.44 %.The third sample initially resulted as 7.68 % and repeated as 5.76 %.The fourth sample initially resulted as 7.92 % and repeated as 6.10 %.The fifth sample initially resulted as 8.75 % and repeated as 6.88 %.The sixth sample initially resulted as 8.21 % and repeated as 6.61 %.The seventh sample initially resulted as 6.75 % and repeated as 5.10 %.The eighth sample initially resulted as 6.95 % and repeated as 5.30 %.The ninth sample initially resulted as 7.08 % and repeated as 5.33 %.The tenth sample initially resulted as 8.88 % and repeated as 7.33 %.The eleventh sample initially resulted as 8.71 % and repeated as 6.92 %.The twelfth sample initially resulted as 7.26 % and repeated as 5.56 %.The thirteenth sample initially resulted as 7.27 % and repeated as 5.43 %.The fourteenth sample initially resulted as 5.87 % and repeated as 3.97 %.The fifteenth sample initially resulted as 7.62 % and repeated as 5.62 %.The sixteenth sample initially resulted as 8.52 % and repeated as 6.84 %.The seventeenth sample initially resulted as 7.52 % and repeated as 5.71 %.The eighteenth sample initially resulted as 7.96 % and repeated as 6.13 %.The nineteenth sample initially resulted as 7.75 % and repeated as 5.97 %.The twentieth sample initially resulted as 9.31 % and repeated as 7.1 %.The twenty-first sample initially resulted as 8.29 % and repeated as 6.74 %.The twenty-second sample initially resulted as 8.20 % and repeated as 6.66 %.The twenty-third sample initially resulted as 9.37 % and repeated as 7.68 %.The patients were not adversely affected.The hba1c reagent lot number was 609659.The reagent expiration date was asked for, but not provided.The field service representative determined that there was an issue with the sample probes on the instrument.He replaced the sample probes.He primed the system, replaced a probe cable, and ran checks.The operator ran calibration, controls, and samples, with no errors.
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