(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 09/21/2015.Retain product was tested and found to be functioning according to specification.Return product was not available.Investigation: the device history record for this lot was reviewed.The lot passed finished goods release criteria.Forty retained cartridges were tested using blood samples which simulate patients undergoing oral anticoagulant therapy.Testing met the acceptance criteria found in q04.01.003 rev v, appendix 1 - product complaint level 2 and level 3 investigation procedure.The complaint was not reproduced.Assessment: pt/inr is monitored over time and any changes to medication would be based on the patient history and dietary information.There is not enough information to determine whether an i-stat product malfunction occurred.The complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.Limits for erroneous results (ler) - patient results inside the ler zone pose a risk to patient safety.When values fall inside the ler zones, potential harm can occur to the patients if these results are utilized in medical decision-making.The ler established for the i-stat pt/inr is 1 inr.
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On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded unexpected results on a patient.There was no additional patient information available at the time of this report.(b)(6) 2015: i-stat inr= 3.7, laboratory inr=6.25.Lab analyzer is acl.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc; however, this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care (b)(4).
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