As a result of a discrepant dat result observed on another provue instrument (see (b)(4)) on (b)(6) 2018, customer reviewed the results of 239 cord blood samples in which the baby was either group a or group b and the mother was group o.These samples had originally been tested on one of four provue instruments during the time period (b)(6) 2018 to (b)(6) 2018.Twenty one samples that had initially been reported as negative were repeated in manual gel.Five samples, originally reported as negative were now weak - 1+ in manual gel testing.Two of the five samples, (b)(6), initially tested on (b)(6) 2018, and (b)(6), initially tested on (b)(6) 2018 are now testing as w-1+ in manual gel.Both samples had initially been tested on provue instrument (s/n (b)(4)).Ortho field engineer (fe) went on site for service.Service was completed on 14jun2018: incubators were calibrated and passed.Centrifuge settings were verified.Camera settings were within range.Reference image was good and clear.Fe verified main screen temperature with meter and both at same reading.Qc was run and verified by customer.Instrument is operating as expected.No repairs were required.Report 1 of 2 (event with sample (b)(6)).
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