Model Number E602 |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/25/2017 |
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 complained of erroneous high results for 15 patient samples tested for elecsys afp assay (afp) on a cobas 8000 e 602 module.The erroneous results were reported outside of the laboratory.Refer to the attached data for patient results.There was no allegation that an adverse event occurred.The afp reagent lot number was 192075 with an expiration date of 31-aug-2018.
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Manufacturer Narrative
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The afp reagent lot number was 21371600.Serial number was updated.Calibration and quality controls were acceptable.
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Manufacturer Narrative
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A specific root cause was not identified.Additional information was requested for investigation but was not provided.The repeat results for each patient were believed to be correct.The initial and repeat results were from the same primary tube.Afp is a high priority test.Since the results were from the same primary tube, a potential carry-over issue influencing the results cannot be excluded.No special maintenance was performed on the instrument between the initial and repeat results.The customer did not have issues with other assays and the issue has not recurred.Based on the available information, an afp assay related issue is not suspected.Possible root causes of the issue may be dirt on the gripper finger or poor sample quality.A general product problem is excluded.
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Search Alerts/Recalls
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