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Catalog Number 06437281190 |
Device Problem
Incorrect Or Inadequate Test Results (2456)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).(b)(4).
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Event Description
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The customer stated that they received questionable results for a total of 245 patient samples tested on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170).Of the 245 patient samples, 89 had erroneous test results.The erroneous results were reported outside of the laboratory to the doctor.The affected assays include: the elecsys afp assay (afp), the elecsys ca 19-9 immunoassay (ca 19-9), the elecsys cea assay (cea), the elecsys total psa immunoassay (psa), elecsys ft3 iii (free-t3), the elecsys ft4 ii assay (free-t4), and the elecsys tsh assay (tsh).Please refer to the medwatches with the following a1.Patient identifiers for information related to each affected assay: (b)(6) = tsh (b)(6) = free-t3 (b)(6) = free-t4 (b)(6) = afp (b)(6) = ca 19-9 (b)(6) = cea (b)(6) = psa.Please refer to the attachment for all patient data.The samples were initially tested on the customer's e170 analyzer (named elecsys on attachment).The elecsys values highlighted in orange are erroneous.The samples were repeated using the abbott architect and wako accuraseed methods.Sample 31 was provided for investigation where it was tested for tsh, free-t3, and free-t4 on a cobas 8000 e 801 module - e801 (see bottom of attachment).No adverse events were alleged to have occurred with the patients.The serial number of the customer's e170 analyzer is (b)(4).The serial number of the e801 analyzer used for investigation was (b)(4).Ft4 reagent lot number 288197, with an expiration date of december 2018 was used on this analyzer.
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Manufacturer Narrative
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The reference ranges for the wako accuraseed methods are as follows: tsh = 0.5 - 4.8 uiu/ml, ft4 = 0.87 - 1.72 ng/dl, ft3 = 2.39 - 3.86 pg/ml.
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Manufacturer Narrative
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Differences in results and reference ranges from thyroid assays by different manufactures, in this case abbott, can vary due to differences in the types of antibodies used, setups of the assays, and standardization methodologies.The investigation could not determine a definitive root cause.
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Search Alerts/Recalls
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