Model Number ELITE |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr references (b)(4) for the hemochron signature elite instrument, serial number (b)(4).Actual device not evaluated.Process evaluation performed.The pcb board, covers and battery were replaced in 2010, but the reason for that service is not related to the current complaint.No results available since no evaluation performed.Device not returned.Accriva diagnostics has requested all data required for form 3500a.Fields for which data were not obtainable or are not applicable are intentionally left blank.An instrument evaluation is anticipated.Results of the evaluation will be submitted as mdr 2250033-2018-00006 follow-up #1.
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Event Description
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A healthcare professional reported discrepant act results with two different hemochron signature elite and act+ microcoagulation systems at the conclusion of a cardiovascular procedure.The signature elite named in this complaint was used during the procedure and the act results recorded were as expected.After protamine was given the act result was 380 seconds, which was higher than expected.Another blood draw was done and split samples were run on the the same elite and on a second elite system.The recorded act results were 408 and 134 seconds, respectively.The result of 134 seconds was as expected.The procedure was completed and no adverse events were reported.
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Manufacturer Narrative
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Mdr 2250033-2018-00006 follow-up #1 reports results of the instrument evaluation on the hemochron signature elite microcoagulation system serial number (b)(4) named in accriva diagnostics' complaint (b)(4).The actual device was evaluated.No failure detected.No failure detected, device operated within specification when liquid quality control materials and blood samples were assayed.Unable to confirm complaint.Accriva diagnostics has requested all data required for form fda 3500-a.No previously unobtainable information reported in the initial mdr is available.
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Event Description
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Follow-up #1.
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Search Alerts/Recalls
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