[61240113]
A customer in (b)(4) contacted biom? Rieux to report a discrepant result (position b1) in association with the vidas? Analyzer. The customer was informed by a physician of an underestimated result for ntprobnp of 299 obtained on (b)(6) 2016. A new sample result (after treatment) of 1721 was obtained on (b)(6) 2016 and a retest of the initial sample was performed on (b)(6) 2016, which resulted in an underestimation again. The physician informed the laboratory of the underestimated results and proceeded to treat the patient appropriately; therefore, there was no incorrect treatment or harm to the patient. The customer also indicated there was a delay in reporting results. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[71025689]
A biomerieux investigation was conducted for an underestimated result for ntprobnp with position b1 in association with the vidas? Analyzer eu. The customer stopped using section b of the instrument for testing and performed a qcv (quality control validation) test. The problem in section b slot 1 was confirmed by the qcv result of 0. 29 (out of range) instead of > 5. 6. A biom? Rieux field service engineer (fse) visited the customer site to investigate the failure. Using a pump tester, the fse identified the root cause of the qcv failure was a clog, due to the dirty seal in section b slot 1. After replacing the pump seal, cleaning the section, and retesting, the results showed that the clog issue was resolved and the instrument was repaired. The fse also performed a leak test and found all sections and slots of the instrument conformed. Biom? Rieux requested a retrospective analysis for all tests which were run on section b slot 1 of the instrument. The retrospective analysis showed that 16 patient samples may have been affected :? For 9 patient samples, the retrospective analysis stated that there was no impact. ? For 6 patient samples, the retrospective analysis stated that the customer will inform the clinician about the possible false result? For 1 patient result, no information is given in order to state if there was impact or not the seven (7) samples for which no information regarding impact was available were processed via ntprobnp and tnhs assays. The vidas? Ntprobnp package insert (ref 30 458) states, "the vidas nt-probnp2 (pbn2) test is used as an aid in the diagnosis of suspected heart failure. " the vidas? Tnhs package insert (ref 415386) states, "the vidas? High sensitive troponin i assay is intended to be used as an aid in the diagnosis of myocardial infarction (mi) and for the risk stratification of patients with symptoms suggestive of acute coronary syndrome (acs) with respect to relative risk of all-cause mortality and major adverse cardiac events (mace) consisting of myocardial infarction and revascularization, at 30 days". This means that for the two (2) assays for the seven (7) patient results which may have been affected, and for which information was not provided, the tests are an aid to the diagnostic. They are not sufficient by themselves, the clinician decision is not based only on the result of these tests. They must be supplemented by further tests. In accordance with the vidas? Ntprobnp package insert (ref. 30 706) and the vidas user manual, qcv testing is to be performed monthly. The customer stated that no qcv test was performed between the last successful qcv in june 2016 and the failed qcv in november 2016.
Patient Sequence No: 1, Text Type: N, H10