Model Number ADVIA CENTAUR XP |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The customer contacted a siemens customer care center (ccc) specialist.The ccc reviewed the data provided.The ccc found that the customer's quality control (qc) was not within range when the patient sample was run.The ccc recalibrated the instrument and ran qc, resulting within range.The customer ran the patient sample, resulting higher.Siemens is investigating the event.
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Event Description
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A discordant, falsely depressed thyroid peroxidase result was obtained on a patient sample on an advia centaur xp instrument.The initial result was reported out to the physician(s).The customer repeated the same sample on the same advia centaur xp instrument, resulting higher.The customer repeated the same sample on the same advia centaur xp instrument again, resulting higher than the initial result.The customer issued a corrected report to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely (b)(6) thyroid peroxidase result.
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Manufacturer Narrative
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The initial mdr 2432235-2017-00204 was filed on march 20, 2017.Additional information (04/13/2017): the siemens headquarters support center (hsc) reviewed the event.The issue was corrected by performing calibration using a new calibrator.Calibration and quality control (qc) were run, resulting within range.The cause of the discordant, falsely depressed thyroid peroxidase result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
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Search Alerts/Recalls
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