Catalog Number 04404483190 |
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 01/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the cobas integra 400 plus is (b)(6).The provided calibration data was ok.Quality controls were ok on the day of the event.A general reagent issue can be ruled out as calibration and quality controls are acceptable.Upon review of the alarm trace from on (b)(6) 2023 to on (b)(6) 2024, there are frequent clot detection alarms.There were also frequent alarms indicating "service cannot be started" and inadequate fluid.The investigation is ongoing.
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Event Description
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The initial reporter stated they received discrepant results for one patient sample tested with cobas integra glucose hk gen.3 on a cobas integra 400 plus.The sample initially resulted in a glucose value of 187.1 mg/dl.The clinician questioned the result since the patient did not have diabetes.The sample was repeated, resulting in a glucose value of 94.4 mg/dl.The repeat value was deemed correct and was reported outside of the laboratory.
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Manufacturer Narrative
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It was determined that the laboratory temperature had a high variability during the day, which could impact tube storage conditions.The inadequate fluid errors can be an indicator of overfilled tubes or incorrectly configured tube settings on the analyzer.The clot alarms are indicative of a general pre-analytic sample handling issue.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.
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Search Alerts/Recalls
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