Model Number C503 |
Device Problems
Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is ongoing.
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Event Description
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There was an allegation of questionable results from the cobas pro c 503 analytical unit.The tech noticed the low results and decided to perform repeat testing on the other c503 module in the laboratory.Patient 1 initial total protein result was 0.559 g/l and the repeat result was 5.39 g/l.Patient 2 initial glucose result was 43.5 mg/dl and the repeat result was 148 mg/dl.The initial creatinine result was 0.116 mg/dl and the repeat result was 0.98 mg/dl.The initial total protein result was 1.22 g/l and the repeat result was 6.22 g/l.Patient 3 initial glucose result was 26.8 mg/dl and the repeat result was 113 mg/dl.The questionable results were not reported outside of the laboratory.The glucose reagent lot number was 596374, the creatinine reagent lot number was 577467, and the total protein reagent lot number was 619900.The expiration dates were requested but were not provided.
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Manufacturer Narrative
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The field service representative found a build-up of serum plasma in the sample probe from a bad sample.He cleaned and flushed out the probe.He ran successful mechanical checks, calibrations, and qc.As the calibration and qc data were acceptable, there was no indication of a reagent issue.The centrifuge time may be too short and the speed may be too high per the tube manufacturer¿s recommended guidelines.The investigation determined the service actions resolved the issue.
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Search Alerts/Recalls
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