The customer complained of erroneous results for 1 patient tested for roche cardiac d-dimer on an h232 instrument.The initial d-dimer result was 0.12 ug/ml.Approximately 1 hour later, the customer ran the sample again and the result was 3.12 ug/ml.The customer only reported the 3.12 ug/ml result to the physician.The customer has been using the h232 instrument for 2 years.On (b)(6) 2017 the field service engineer (fse) ran instrument verification and the quality control results were acceptable.There was no allegation that an adverse event occurred.The h 232 instrument serial number was (b)(4).Neither the h232 instrument nor a similar device is sold in the united states.The meter and strips were requested for investigation.Relevant retention material (roche cardiac d-dimer of lot 19752510) was measured on a cobas h232 used at the investigation site with: two native blood samples and one spiked blood.Sample (c=3.00 ¿g/ml), each blood sample n= three test strips.The mean of the measurements on the cobas h232 used at the investigation site: first native blood sample: 0.12 ¿g/ml, second native blood sample: 0.21 ¿g/ml, spiked blood sample (c=3.00 ¿g/ml): 2.80 ¿g/ml.The results of all measurements fulfill the requirements.
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