Catalog Number 07528582190 |
Device Problems
Low Test Results (2458); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The c702 module serial number was (b)(6).On 07-dec-2023, before the event, level 1 qc was acceptable; level 2 qc initially failed and upon repeating was acceptable.After the discrepant results were identified, both levels of qc failed.On (b)(6) 2023 qc was run on the same reagent pack and both levels of qc were acceptable.The investigation is ongoing.
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Event Description
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The initial reporter questioned low results for 110 patient samples tested for hdlc4 on a cobas 8000 c 702 module.Due to the low results, the customer repeated the patient samples.Of the data provided, the results for 4 patient samples were discrepant.Patient 1 initial result was 28 mg/dl.The repeat result was 51 mg/dl.Patient 2 initial result was 30 mg/dl.The repeat result was 53 mg/dl.Patient 3 initial result was 26 mg/dl.The repeat result was 54 mg/dl.Patient 4 initial result was 22 mg/dl.The repeat result was 46 mg/dl.
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Manufacturer Narrative
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An abnormal aspiration alarm was observed on the alarm trace data from (b)(6) 2023.The sample draw volume of 2.5 ml may be too low.The field service engineer (fse) checked the instrument.No actions were taken other than replacing the reagent with a new pack from the same lot number.Based on a review of worldwide data of qc recovery for the reagent/control lot combination used by the customer, no reagent issue was found.It appears that replacing the reagent pack resolved the issue.The investigation did not identify a product problem.The specific cause of the event could not be determined.
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Search Alerts/Recalls
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