Model Number N/A |
Device Problems
Calibration Problem (2890); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/07/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The cause for the discordant ft4 results is unknown.Siemens healthcare diagnostics has requested additional information and also requested if the patient samples are available for further testing and investigation.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
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Event Description
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False low advia centaur xp ft4 results were obtained for samples from four patients.The patients had normal tsh3-ultra results.The clinical picture of the patients did not display illness.The physician questioned the ft4 results.The customer tested random patient samples with normal tsh results on the advia centaur xp ft4 assay.There were false low ft4 results for three patients.The patient samples were tested on an alternate method in a different laboratory for ft4 and tsh.The ft4 and tsh results were normal.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ft4 result.
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Manufacturer Narrative
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On 10/20/2016 additional information: (b)(6).Siemens healthcare diagnostics is investigating.
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Manufacturer Narrative
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Siemens filed the initial mdr 1219913-2016-00186 on october 19, 2016.Siemens filed the mdr 1219913-2016-00186 supplemental report 1 on november 9, 2016.On 01/05/2017 additional information: siemens has performed an internal investigation and has confirmed a negative bias for the advia centaur ft4 when used with calibrator a kit lots ending in 90 on the advia centaur, advia centaur xp and advia centaur xpt systems.In addition, siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay.Siemens issued ufsn cc 17-04.A.Ous (january 2017) and umdr cc 17-04.A.Us (january 2017) informing the customer of ft4 assay negative bias observed with calibrator a kit lots ending in 90.Instructions on actions to be taken are provided in the customer communication.
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Search Alerts/Recalls
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