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 11/10/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The cause for the discordant advia centaur xp ft4 results is unknown.The calibration and qc were valid at the time the samples were run.The calibrator used was lot ca90.Siemens healthcare diagnostics is investigating.The interpretation of results section of the instructions for use states: "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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The customer observed two samples with depressed advia centaur xp ft4 results compared to the clinical picture of the patients.The results were reported to the doctor and the doctor questioned the results.There are no reports that treatment was altered, prescribed or delayed due to the depressed results.There are no reports of adverse health consequences due to the depressed advia centaur xp ft4 results.
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Manufacturer Narrative
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On 01/19/2017 additional information: recall number: 1219913-01/10/2017-002-r.
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Manufacturer Narrative
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Siemens filed the initial mdr 1219913-2016-00230 on november 18, 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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