Catalog Number 09793194001 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The cobas c 303 analytical unit serial number was (b)(6).The investigation is ongoing.
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Event Description
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There was an allegation of questionable magnesium (mg2) results from the cobas c 303 analytical unit.The initial result was 2.8 mg/dl.The doctor questioned the result and the sample was repeated with a result of 2.1 mg/dl.The repeat result was deemed correct.
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Manufacturer Narrative
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The field service engineer found there was a low rinse volume on the reagent probe.He ran precision testing and noticed the customer was using a different lot number of calibration material than what was programmed in the system.He checked the pump pressure and gear pump pressure which were within specifications.He cleaned a solenoid valve and a valve for the reagent probe rinse.He adjusted the probe rinse, cleaned the probe, and confirmed the rinse mechanism levels were within specifications.He recalibrated and ran qc which passed.He ran a carryover check which passed.The investigation determined the service actions resolved the issue.
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Search Alerts/Recalls
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