On (b)(6) 2015 a (b)(6) customer reported a false elevated result obtained with vidas® dimer exclusion ii (tm), ref (b)(4), lot 1004051950 (expiration date: 18-may-2016).The patient ((b)(6) woman) suffered from a chest pain.No additional patient information was provided.The vidas® dimer exclusion ii (tm) test was performed on (b)(6) 2015 and the result was positive (645.66 ng/ml).The instructions for use (ifu) of the test d dimer exclusion ii ref.(b)(4), state that : "in a study carried out using 215 citrated plasma samples from blood donors, 90% of values were below 500 ng/ml (feu).The result were given to the physician who decided to hospitalize the patient due to the vidas® dimer exclusion ii result.An additional test d-dimer (it is unknown which method was used) gave a negative result (350 ng/ml for a threshold at 400 ng/ml).
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