(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 09/27/2017.Retain product was tested and found to be functioning according to specification.Return product was not available.Investigation: a review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained cartridge testing of pt/inr cartridge lot s17079 met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ab (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for pt/inr cartridge lot s17079.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification. the patient is on warfarin and therefore an pt/inr in the range of 2-4 inr would be expected depending on warfarin dosage, other medications and diet. on the day in question, the result on the laboratory is higher than the history for this patient.
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On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded unexpected results on a (b)(6) male patient with mitral valve repair.There was no additional patient information available at the time of this report.Return product is not available.(b)(6).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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