Model Number IMMULITE 2000 XPI - CMB |
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 08/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The customer contacted siemens customer care center (ccc).Siemens headquarters support center (hsc) is reviewing the provided results, the instrument files, and the error logs.The cause for the discordant, falsely elevated cmb sample result is unknown.Siemens is investigating the issue.Mdr 2432235-2019-00310 was filed for the same issue.
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Event Description
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One discordant, falsely elevated creatine kinase isoenzyme - mb (cmb) result was obtained on immulite 2000 xpi instrument.The initial result was not reported to the physician(s).The same sample was repeated using the same immulite 2000 xpi instrument.The repeat result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated cmb result.
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Manufacturer Narrative
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Siemens filed initial mdr 2432235-2019-00311 on 5-sep-2019.Additional information (23-oct-2019): siemens headquarters support center (hsc) has reviewed the information provided by the customer.Hsc review of the system data indicates that there were no sample and reagent level sense issues or any instrument errors that would cause the discordant results.The customer observed multiple discordant elevated/depressed troponin i and ckmb results on their immulite 2000 xpi system over a period of months.These samples when repeated without re-centrifugation generated the expected result.Hsc observed that the original instrument was swapped out to a new immulite 2000 xpi instrument after several repair attempts.The issue was not resolved after the instrument replacement which ruled out a hardware issue.The customer's reagent was sent to another site and ran several samples without issue of discordant results.Siemens field application specialist (fas) was dispatched to the customer site to observe the sample handling process for 5 days and found several issues.Fas provided proper sample handling recommendations to the customer.No product performance issue was identified.No other issues have been reported by the customer post fas visit and the actions performed resolved the reported issue.The instrument is performing within specification.No further evaluation of the device is required.Mdr 2432235-2019-00310-s1 was filed for the same event.
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Search Alerts/Recalls
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