Catalog Number 08057800190 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/29/2024 |
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 gluc3 glucose hk gen.3 results for 1 patient sample on a cobas c 503 analytical unit.The initial glucose result was 39.3 mg/dl.The nurse questioned the result as they had performed an istat point of care glucose test on the patient's unit and the result was 300 mg/dl.The sample was repeated on another c503 analyzer and the repeat result was 324 mg/dl.The repeat result was deemed correct.
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Manufacturer Narrative
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Section d product information has been updated, as well as g1 manufacturing site and g4.The field service engineer (fse) found that the rinse levels were low and cleaned the rinse head flow path.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.
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Search Alerts/Recalls
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