ABBOTT DIAGNOSTICS DIVISION/CELLDYN CELL-DYN RUBY ANALYZER AUTOMATED HEMATOLOGY ANALYZER Catalog Number 8H67-01 Device Problem High Test Results Event Date Event Type Malfunction Event Description The customer stated a platelet result of 20. 5 k/ul generated on the cell-dyn ruby was reported and questioned by the physician. The patient sample was repeated with a result of 24. No platelet flags were generated. 2017 Ducati Monster 1100s Workshop Manual download more. A manual count was performed confirming a platelet count of 17. The customer stated manual counts are not required on platelet results above 12 k/ul with no flags.
A review of control values showed that platelet results were biased high. Barber Coleman Limitrol Manual download free. Service was requested to resolve the issue. No impact to patient management was reported. Manufacturer Narrative This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Manufacturer Narrative In response to this issue an investigation was conducted that included a review of the complaint text and data, a review of labeling, and a review of tracking and trending. A review of the customer data found that all of the results from the cbc test selection had rbc morph flagging. The plt results from the cbc+rrbc test selection were higher with no mpv result (mpv >>>>).
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Abbott Cell Dyn Ruby Service Manual Abbott core laboratory personalized laboratory solutions ©2016 abbott, abbott park, illinois, u.s.a. Hematology Analizer Cel-dyn Rubby The CELL-DYN Ruby System* is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in medium volume clinical laboratories.
All plt results from cbc or cbc+rrbc modes had dispersional data alerts (underlined results). The cell-dyn ruby system operator's manual, revision d, section 3: principles of operation, provides suggestion to review stained smear for abnormal rbc or plt morphology when rbc morph flagging is present.