Model Number IMMULITE 2000 XPI |
Device Problems
Detachment Of Device Component (1104); Nonstandard Device (1420); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/17/2014 |
Event Type
malfunction
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Event Description
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The operator of immulite 2000 xpi instrument observed error messages while samples were processing.The error messages were produced because the cap that secures the water bottle probe to the water bottle had detached, displacing the probe.There are no reports of any impact to patient results during this event.
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Manufacturer Narrative
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Siemens healthcare diagnostics is conducting a correction for the immulite 2000 and immulite 2000 xpi immunoassay systems water and liquid waste bottles received starting may 2013.Siemens has identified that the water and liquid waste bottle assemblies were manufactured with a quality issue.The smaller diameter opening of both bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.Urgent medical device correction (umdc) 2015-03-05 entitled "immulite 2000 and immulite 2000 xpi water and liquid waste bottles issue" was sent to customers in the united states and urgent field safety notice (ufsn) 3022 entitled "immulite 2000 and immulite 2000 xpi water and liquid waste bottles issue" was sent to customers outside the united states in march 2015.The umdc/ufsn describes how to identify a defective bottle and actions to take if a defective bottle is identified.
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Search Alerts/Recalls
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