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Catalog Number 04388780190 |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/17/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).
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Event Description
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The customer reported that the values obtained with a roche instrument for one sample tested for the following tests did not fit the clinical picture of the patient: testosterone (testo), dehydroepiandrosterone sulfate (dhea-s), antibodies to tsh receptor (anti-tshr), free triiodothyronine (ft3), free thyroxine (ft4), and thyrotropin (tsh).Testo, dhea-s, anti-tshr, ft3, and ft4 values were said to be very high.The tsh value was said to be normal.The sample was tested for anti-tpo and anti-thyroglobulin using the liaison testing method and the results for these tests were positive.The sample was also tested for androstanediol glucuronide and androstenedione using an ria testing method and results from these tests were normal.The results obtained with the roche methods and other methods were said to not fit with each other.All results were sent to the physician.The customer also mentioned that another sample was collected from the patient in the same year and tested for the same tests using the roche method at a different laboratory and these results were similar to the sample in question.No specific result values were provided for any of the questioned samples.This medwatch will cover anti-tshr.Patient identifier (b)(6) for information related to ft3.Patient identifier (b)(6) for information related to ft4.Patient identifier (b)(6) for information related to tsh.Patient identifier (b)(6) for information related to testo.Patient identifier (b)(6) for information related to dhea-s.The patient was not adversely affected.The analyzer model and serial number used for testing was asked for, but not provided.
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Manufacturer Narrative
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The customer has provided the patient data.Please refer to the attachment for all data, including relevant test data.Data was provided for samples from the same patient tested on (b)(6) 2013, (b)(6) 2015, and for the complained sample tested on (b)(6) 2015.The ft3 test is referred to as "t3 libre", ft4 is referred to as "t4 libre", anti-tshr is referred to as "anti-thyroglobuline", testo is referred to as "testosterone totale", and dhea-s is referred to as "dhea sulfate".
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Manufacturer Narrative
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The customer provided data for a new sample that was tested from the patient on 01/28/2016.The sample was said to have similar values to previous samples.Please refer to the attachment for the result data from this sample.In the attachment, the ft3 test is referred to as "t3 libre", ft4 is referred to as "t4 libre", anti-tshr is referred to as "anti-thyroglobuline", testo is referred to as "testosterone totale", and dhea-s is referred to as "dhea sulfate".The patient was not suffering from a known renal insufficiency, a known liver insufficiency, or a known malignant disease.The patient was not pregnant.(b)(4).
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Manufacturer Narrative
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A sample from the patient was provided for investigation.Investigation of the sample determined that it contains an interfering factor to streptavidin.This interfering factor most likely caused the elevated values for anti-tshr.This limitation is covered in product labeling.
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Search Alerts/Recalls
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