C-REACTIVE PROTEIN GEN.3 04956842190

[22725554] This event occurred in (b)(6). (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[22725555] The customer initially complained of out of range quality controls (qc) for c-reactive protein gen. 3 (crpl3). The cassette with out of range qc was removed and 2 new cassettes were loaded. The customer only ran calibration and qc on the 2nd cassette and did not realize they were using a cassette without valid qc. After loading the 2 new cassettes, 125 patient samples were re-run. No additional information was provided regarding these samples. The next day qc was run again and the results were not within the acceptable range. They discarded the cassette that was not acceptable and re-ran 128 patient samples. It was discovered that 78 of these patient samples had an approximate 30% difference in recovery. The erroneous results had been reported outside of the laboratory and the results had to be corrected. The date of event for these 78 patient samples is not clear. No patient specific information has been provided. The specific results have not been provided. No adverse event occurred. The c501 analyzer serial number was (b)(4). It was noted that the 1st cassette was calibrated on a pack that was not mixed and the 2nd cassette used the same calibration. After the customer used a fresh pack and the reagent lot was calibrated appropriately, all qc and patient samples have been correct. A specific root cause could not be identified.
Patient Sequence No: 1, Text Type: D, B5

[32496535] Based on the data provided, calibration was performed on 5 crp reagent cassettes with lot 608660 between (b)(6) 2015 and (b)(6) 2015. It was determined that the issue was caused by the reagent cassette from (b)(6) 2015. The customer changed their work process related to performing quality controls on standby reagent cassettes to avoid future confusion.
Patient Sequence No: 1, Text Type: N, H10