Investigation conclusion: the customers complaint was not replicated with in-house testing of retains of lot t10741n.No issues with d-dimer recovery were observed.Manufacturing batch records for lot t10741n were reviewed and found that the lot met final release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.Although this catalog number (97300eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 97300, 510(k) number k080269.
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Customer reported elevated triage d-dimer results for one patient.Triage produced the following results: 3970ng/ml, 1310ng/ml and >5000ng/ml.Patient received a ct scan.Results of the scan were "negative".Although requested, no additional details were provided around this event.
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