On 12/07/2015, abbott point of care was contacted by a customer regarding i-stat b-hcg cartridges that yielded suspected false positive results on a female patient who presented with shortness of breath and was diagnosed with substance abuse, myoclonus, anxiety reaction, and urinary tract infection (uti).There was no additional patient information available at the time of this report.Analyzer: i-stat; date drawn: (b)(6) 2015; time drawn: 2310; result: >2,000.Siemens vitros; (b)(6) 2015; 2310; <1.I-stat; (b)(6) 2015; 0140 ; >2,000.Siemens vitros; (b)(6) 2015 ; 0140 ; <1.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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