Catalog Number B4218 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/15/2014 |
Event Type
malfunction
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Manufacturer Narrative
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Siemens healthcare diagnostics has confirmed complaints about downward drifting recovery of control plasma p lot 509964 with lot 538480 of dade® actin®fs activated ptt reagent on the bcs/bcs xp system.The impact on patient sample recovery with the dade actin fs activated ptt reagent lots was investigated.The investigation showed no effect on patient sample recovery.No lookback for previously reported patient test results was recommended.No us customers received the affected product.A customer letter was distributed to outside us customers.An outside us customer letter br-02315 dated march 2015 was issued to the potentially impacted customers.The communication was sent to inform those customers using the combination of actin fs and control plasma p on the bcs/bcs xp system about the issue and to recommend usage of an alternate control plasma p lot of dade ci-trol 2/citrol 3 as pathological control instead of control plasma p.
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Event Description
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A customer complained of downward drift of control plasma p (cpp) control recoveries with actin fs activated ptt reagent on the bcs system.Patient samples were run during the period of control recovery drift.The complainant gave no indication of patient sample results being questioned by physicians during the period of control recovery drift.There is no indication of patient treatment being altered or prescribed during the period of control recovery drift.There was no report of adverse health consequences during the period of control recovery drift.
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Manufacturer Narrative
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Siemens healthcare diagnostics inc.Filed the initial mdr (9610806-2016-00004) on february 11, 2016.February 12, 2016 additional information: no us customers received the affected product.A customer letter was distributed to outside us customers.The outside us customer letter br-04815 dated june 2015 was issued to the potentially impacted customers.The communication was sent to inform those customers using the combination of actin fs and control plasma p on the bcs/bcs xp system about the issue and to recommend usage of an alternate control plasma p lot of dade ci-trol 2/ci-trol 3 as pathological control instead of control plasma p.
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Search Alerts/Recalls
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