VITROS CHEMISTRY PRODUCTS CRBM SLIDES 8892382

[110471850] The investigation determined that a higher than expected results were obtained from lithium heparin plasma samples obtained from a whole blood pool, when compared to vitros crbm results obtained from serum samples obtained from the same whole blood pool. Vitros na heparin plasma results were also higher than expected but did not exceed potential health and safety criteria. The higher than expected vitros crbm results were obtained from three different vitros crbm slide lots tested on a vitros 5600 integrated system. The most likely assignable cause of the higher than expected vitros crbm results could not be determined. A total of 71 sample sets were processed to compare crbm results generated from plasma (li and na heparin) to serum values. Li and na heparin results obtained from 70 of the 71 sample sets were comparable to the serum results, with only the affected sample set identified in this issue generating higher than expected li heparin plasma results. Therefore, a positive bias associated with plasma versus serum samples did not likely contribute to the event. In addition, there was no indication the vitros crbm slides or the vitros 5600 system malfunctioned. Quality control testing was performed at the beginning and end of each test event and the results were within the expected intervals. In addition, the vitros 5600 integrated system was qualified per internal ortho procedures indicating the system was operating as expected. Finally, no pre-analytical user error involving sample processing was identified.
Patient Sequence No: 1, Text Type: N, H10

[110471851] A customer reported higher than expected vitros crbm results were obtained from lithium heparin plasma samples obtained from a whole blood pool, when compared to vitros crbm results obtained from serum samples obtained from the same whole blood pool. The higher than expected vitros crbm results were obtained from three different vitros crbm slide lots tested on a vitros 5600 integrated system. (b)(6). Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. No patient samples were affected as the testing was internal to ortho, however; the investigation cannot conclude that patient sample results could not be affected or would not be affected if the event were to recur undetected in a health care setting. There was no report of patient harm as a result of this event. This report is number two of three 3500a forms filed for this event, as three devices were affected. (b)(4).
Patient Sequence No: 1, Text Type: D, B5