[81420929]
The investigation confirmed that unexpected vitros amon results were obtained using a single level of non-vitros biorad quality control and a single level of vitros quality control using two different vitros amon slide lots tested on two different vitros 5600 integrated systems. The investigation concludes that the phs event that occurred on vitros j56000563 was most likely an instrument related issue and was resolved by service actions. The customer observed non-reproducible results initially on amon slide lot 1017-0245-8847. The customer then calibrated alternate amon lot 1017-0245-0209 and the quality control results post calibration were still unacceptable. The same vitros lpv and biorad quality control fluids were acceptable on an alternate analyzer after calibration of the alternate amon lot indicating that the qc fluids themselves are not a likely contributor to the event. An ortho fe performed service actions to the reflectometer subsystem which include replacing mirror/lens, lamp and lamp assembly on vitros j563 analyzer. It was confirmed that acceptable amon qc results have been maintained following service actions. The assignable cause for the event that occurred on vitros j56000562 is unknown. The inventory of vitros amon lot 1017-0245-8847 was depleted and therefore, it was not possible to further investigate that slide lot. The customer performed no troubleshooting actions other than calibration of an alternate amon slide lot 1017-0245-0209 and acceptable quality control results post calibration were obtained. There was no indication of an instrument malfunction.
Patient Sequence No: 1, Text Type: N, H10
[81420930]
The investigation determined unexpected ammonia results were obtained from a single level of non-vitros biorad quality control and a single level of a vitros quality control fluid when using two different vitros amon slide lots on two different vitros 5600 integrated systems. J56000563 with amon lot 1017 0245 8847, biorad level 3 lot 51990 = 159. 05, 164. 63, 157. 43 versus expected 216. 5 umol/l, lpv ii lot x5010= 101. 66 versus expected 169. 5 umol/l. J56000563 with amon slide lot 1017 0245 0209, biorad level 3lot 51990= 170. 7 versus expected 216. 5 umol/l. Lpv ii lot x5010= 120. 9 versus expected 169. 5 umol/l. J56000562 with amon lot 1017 0245 8847, biorad level 3 lot 51990= 169. 915 versus expected 216. 5 umol/l, lpv ii lot x5010= 113. 641, 117. 47 versus expected 169. 5 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action, should they occur undetected on patient samples. The customer did not process patient samples as the quality control results were not acceptable, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. This report is number one of four 3500a forms filed for this event, as four devices were affected. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5