[129157436]
A customer from (b)(6) notified biom? Rieux of obtaining elevated ck-mb results for a (b)(6) boy in association with the vidas? Ck mb assay (ref (b)(4)). Although product reference (b)(4) is not sold/ distributed in the united states, a similar product is (reference (b)(4)). The patient had complained of a stabbing pain his chest after exercise. He had moved benches at school and played football. He was admitted to the children's ward for observation, and labs were drawn showing the following results: (b)(6) 2018: troponin - 10. 1 ng / ml, ck-mb - 116. 15 ng / ml, ecg - normal. (b)(6) 2018: troponin - 3. 6 ng / ml, ck-mb - 133. 97 ng / ml. (b)(6) 2018: ck-mb - 202. 99 ng / ml, repeated in serum diluted 11 times = 17. 1 ng / ml x 11 = 188. 1 ng / ml. The chest pain was transient, and the patient was reported by the customer as feeling well. As the vidas ck-mb test was performed after a sport exercise at school, the elevation of ck-mb could have been due to muscular hyperactivity. However, the result continued to increase. The customer reported testing one of the patient samples with the vidas ckmb assay and obtaining a > 300 result. This same sample was testing with cobas? (roche diagnostics), and it returned a ck-mb result in the normal range. The customer reported that the patient was discharged home without treatment. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. Note: the two techniques, vidas and cobas, use different technologies and different antibodies for the detection of ck-mb. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5