Catalog Number 04404483190 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The cobas 6000 c 501 serial number was (b)(6).The investigation is ongoing.
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Event Description
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There was an allegation of a questionable gluc hk gen.3 (glucose) result from the cobas 6000 c 501.The initial result was 2 mg/dl and was reported outside of the laboratory.The repeat result was 77 mg/dl and was believed correct.
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Manufacturer Narrative
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The customer canceled a scheduled service visit and stated they resolved the issue by recalibrating the assay.The investigation determined the customer's actions resolved the issue.
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Search Alerts/Recalls
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