Catalog Number 20767107322 |
Device Problems
Incorrect Measurement (1383); High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The analyzer serial number is (b)(6).The investigation is ongoing.
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Event Description
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There was an allegation of questionable trigl triglycerides results for 1 patient sample on a cobas 4000 c311 stand alone system.On (b)(6) 2023, the initial trigl result was 413 mg/dl.The customer questioned the high result and repeated the sample.On (b)(6) 2023, the first sample was repeated in a sample cup and the result was 97 mg/dl.On (b)(6) 2023, the original sample tube was repeated twice and the results were 104 mg/dl and 106 mg/dl.
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Manufacturer Narrative
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It was found that the customer centrifuges patient samples for 10 minutes at 3000 g, which is too fast of a speed.The customer provided a picture of the patient sample which showed red strands in the gel barrier.Based on the available data, a general reagent issue could be excluded.The root cause of the event was found to be consistent with pre-analytical sample handling issues.
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Search Alerts/Recalls
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