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 10/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer complained of erroneous results for 1 patient sample tested for elecsys total psa immunoassay (total psa) on a cobas 8000 e 602 module.The initial total psa result was 11 ng/ml.This result was reported outside of the laboratory where it was questioned by the physician.The sample was repeated on the same instrument and the result was 0.04 ng/ml.The sample was also repeated on a 2nd e602 module and the result was 0.04 ng/ml.The results of 0.04 ng/ml were believed to be correct.The customer doesn¿t believe the patient received any treatment based on the initial result released from the laboratory.The physician stated the patient was under a cursory review and the results were being reviewed but no action had been taken yet.There was no allegation that an adverse event occurred.The total psa reagent lot number was 21602700.The expiration date was not provided.The field service engineer (fse) visited the customer site and did not identify an issue.An analyzer baseline check was performed and no abnormalities were noted.Instrument tests passed.The customer ran quality controls within the acceptable ranges.
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Manufacturer Narrative
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Total psa reagent expiration date was (b)(6) 2018.Calibration signals from (b)(6) 2017 and (b)(6) 2017 were lower than expected.No issues were identified during a review of the alarm trace.The measuring cell of the instrument was installed in (b)(6) 2016.
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Manufacturer Narrative
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A specific root cause was not identified.Possible root causes may be dirt on the gripper finger or contamination.Additional possible root causes for this event may be insufficient electromagnetic interference lab compliance, sample quality, insufficient maintenance, or contamination of the environment with the analyte.A general product problem has been excluded.
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Manufacturer Narrative
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The customer has not had any further issues.
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Search Alerts/Recalls
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