Apoc incident # (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 s17048 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 s17048.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 double 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 atrial fibrillation and hip replacement.There was no additional patient information available at the time of this report.Return product is not available.Date of testing: (b)(6) 2017, inr results: i-stat >6.0, lab 2.4.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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