Model Number IMMULITE 2000 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/11/2015 |
Event Type
malfunction
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Manufacturer Narrative
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A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse replaced the sample probe and the dual resolution dilutor (drd).The cse performed precision testing, which was acceptable.The cause of the discordant, falsely low igf-1 results on multiple patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
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Event Description
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Discordant, falsely low insulin-like growth factor 1 (igf-1) results were obtained on multiple patient samples on an immulite 2000 instrument.The discordant results were reported to the physician(s), who questioned them.The samples were repeated on the same instrument, resulting higher.It is unknown if the corrected results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low igf-1 results.
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Manufacturer Narrative
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The initial mdr 2247117-2016-00004 was filed on january 08, 2016.Corrected information (02/01/2016): mdr 2247117-2016-00004 was filed with a date of 12/15/2015.The correct date is 12/04/2015.This has been corrected.
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Search Alerts/Recalls
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