(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 05/09/2016.Retain product was tested and found to be functioning according to specification.Pt/inr lot b15300b: expiration date 04/14/2016; date of manufacture 10/27/2015, pt/inr lot b15326: expiration date 05/14/2016; date of manufacture 11/22/2015.Investigation: the device history record for this lot was reviewed.The lots passed finished goods release criteria.Forty retained cartridges from each lot were tested using blood samples which simulate patients undergoing oral anticoagulant therapy.Testing met the acceptance criteria found in q04.01.003 rev x, appendix 1 - product complaint level 2 and level 3 investigation procedure.The complaint was not reproduced.Assessment: 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 lots are 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) 2016, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded unexpected results on an (b)(6) male patient.There was no additional patient information available at the time of this report.Date of testing: (b)(6) 2016.Method: i-stat, result time: 08:22, inr: 3.3, pt: unknown, sample: a; lab 08:30, 1.05, unknown, b.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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