Catalog Number 08058687190 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the customer's cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
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Event Description
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The initial reporter received a questionable trigl triglycerides result from one patient sample tested on the cobas pro c 503 analytical unit.The initial result was 271 mg/dl.The repeat result was 129 mg/dl.
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Manufacturer Narrative
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The field applications specialist (fas) reviewed the event and determined the event was due to a preanalytic issue at the customer site.The fas inspected 30 random patient sample tubes and noted that 12 patient sample tubes had fibrin and gel when the tubes were inverted.The investigation did not identify a product problem.
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Search Alerts/Recalls
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