ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS GLU SLIDES; IN-VITRO DIAGNOSTICS
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Model Number 1707801 |
Device Problems
Low Test Results (2458); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2023 |
Event Type
malfunction
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Event Description
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A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, lower than expected glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu slides lot 0023-3231-5678 on a vitros xt 7600 integrated system.Patient sample result of 81 mg/dl vs an expected result of 510 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, lower than expected vitros glu result was reported from the laboratory.However, the result was questioned, and no treatment was initiated, altered or stopped based upon the reported result.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
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Manufacturer Narrative
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The investigation has determined that a non-reproducible, lower than expected glucose (glu) result was obtained from a single patient sample processed using vitros chemistry products glu slides lot 0023-3231-5678 on a vitros xt 7600 integrated system.A definitive assignable cause of the event could not be determined.Based on historical quality control results, a vitros glu lot 0023-3231-5678 performance issue is not a likely contributor to the event.An individual slide related issue could not be entirely ruled out as a contributing factor of the event.As no precision testing was performed on the vitros xt 7600 integrated system, an instrument related issue cannot be entirely ruled out as a contributor of the event.However, there was no indication that the analyzer malfunctioned, and historical qc results were precise indicating that an issue related to the performance of the vitros xt 7600 system was not a likely contributing factor of the event.Pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros glu reagent lot 0023-3231-5678.
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