Model Number E411 DISK |
Device Problem
Low Test Results (2458)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This event occurred in (b)(6).
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Event Description
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The customer received a questionable low elecsys afp assay result for one patient sample.The initial result was 4.00 iu/ml and was reported outside the laboratory.The patient had a sacrococcygeal soft tissue mass between gluteal muscles (yolk sac tumor).After an operation, the mass was determined to be malignant and the laboratory was informed.The same sample was repeated 10 times on (b)(6) 2017 and the result was consistently >1000 iu/ml with a data flag.There was no allegation of an adverse event.The reagent lot number was 17674700 with an expiration date of 10/31/2017.The current date set on the analyzer was backdated for an unknown reason.Review of the provided calibration data did not find any issues and confirmed it was acceptable.
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Manufacturer Narrative
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A specific root cause could not be identified.Possible causes include improper pre-analytic handling or bubbles or foam on the reagent surface.Typical causes for this type of event include issue with the sample quality or insufficient maintenance of the analyzer.Based on the information provided, a general product problem was excluded.
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Search Alerts/Recalls
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