VITROS CHEMISTRY PRODUCTS CRBM SLIDES 8892382

[20448037] The customer reported that higher than expected crbm, lac and phyt results were obtained from multiple investigational-only samples when using vitros chemistry products crmb, lac and phyt reagents on a vitros 5,1 fs instrument. (b)(6). Biased results of the magnitude and direction observed may lead to inappropriate physician action. Patient results were not affected; however, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of these events. This report is number two of twelve mdr? S for this event. Twelve 3500a forms are being submitted for this event as twelve devices were involved. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

[20689809] The investigation determined that higher than expected crbm, lac and phyt results were obtained from multiple investigational-only samples when using vitros chemistry products crmb, lac and phyt reagents on a vitros 5,1 fs instrument. The assignable cause of the events is most likely related to the n-acetyl cysteine (nac) that was added to the samples, and interferes with the vitros crbm, lac and phyt micro slide assays. The investigation is ongoing. A vitros micro slide issue cannot be ruled out for any of the affected assays; however, the investigation was able to rule out an unexpected vitros 5,1 fs system malfunction.
Patient Sequence No: 1, Text Type: N, H10