Investigation conclusion: customer reviewed their latest cap proficiency testing; performed in (b)(6) 2020.Results of that survey showed acceptable results when using triage d-dimer lot t11341n.The customer's complaint was not replicated during in-house testing of retain device lot t11341n.Retains of the complaint lot were tested with a positive calibrator, no issues with d-dimer recovery were observed.Lot performed within specification.Manufacturing batch records for lot t11341n 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.
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Customer called stating that triage was reporting lower d-dimer results compared to (b)(6) lab immunoturbidometric test.On (b)(6) 2020, (b)(6) year old patient with symptoms of feet swelling for over 3 weeks was tested on triage and quest.Triage d-dimer resulted 314ng/ml ddu.Quest resulted = 0.70mcg/ml feu.Patient did not want any further scans done.Patient choosing to monitor symptoms.Customer stated, "so far no adverse outcomes".Site cut-offs: triage d-dimer: 400ng/ml ddu, quest: 0.50mcg/ml feu.
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