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Catalog Number 33880 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Code Available (3191)
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Event Date 07/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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The customer did not provide patient demographics such as age, date of birth, gender, weight, ethnicity, and race.The access free t4 reagent was not returned for evaluation.A beckman coulter field service engineer (fse) was dispatched to the customer's site to evaluate the system.No hardware malfunction was detected.No hardware errors, flags or other assay issues were reported in conjunction with this event.In conclusion: the cause of the low access free t4 result cannot be determined with the available information.
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Event Description
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The customer reported obtaining a low free thyroxine (access free t4) result for one (1) patient involving one of two unicel dxi 800 access immunoassay systems (serial (b)(4)).The customer could not provide information on which of the two analyzers were in use for this event.The low access free t4 result was released from the laboratory.A physician indicated there was a change made to patient medication, for one patient; however, no further details are available.The customer provided additional questioned low access free t4 results for twenty six (26) patient samples, it is unknown which patient was affected by the change to medication.Quality control (qc), calibration and system check were performing within assay and instrument specifications at the time of the event.No hardware errors, flags or other assay issues were reported in conjunction with this event.The patient sample was serum, collected in a serum separator tube with gel.The customer did not provide additional sample collection and handling information such as centrifugation speed and time.No issues with sample integrity were reported.A beckman coulter field service engineer (fse) fse was dispatched to evaluate instrument performance.
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Search Alerts/Recalls
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