SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)
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Model Number N/A |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2024 |
Event Type
malfunction
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Event Description
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Eight (8) discordant falsely elevated carbon dioxide, concentrated (co2_c) results on seven (7) patient samples were obtained on an atellica ch 930 analyzer.The falsely elevated results were not reported to the physician(s).The same samples were reprocessed on the same atellica ch 930 analyzer.Lower results, considered correct, were obtained and reported.There are no known reports of patient intervention and adverse health consequences due to the falsely elevated carbon dioxide, concentrated (co2_c) results.
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Manufacturer Narrative
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A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding eight (8) falsely elevated carbon dioxide, concentrated (co2_c) results on seven (7) patient samples obtained on an atellica ch 930 analyzer.Quality control (qc) recovered within the customer¿s expected ranges on the event date.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data files.The hsc review of the instrument data files showed that a co2_c reagent well exhibited atypical performance.Calibrations performed on that reagent well had much higher than typical milli-absorbance units (signal) on the level 2 calibrator.When the analyzer began using a new reagent well, it did not perform in the same manner as the previous well, which generated the falsely elevated patient results.The customer discarded the co2_c reagent pack as part of standard troubleshooting and performed a lot calibration on a new co2_c reagent pack.Hsc determined that co2_c reagent well was contaminated.There was no hardware issue observed with the atellica ch 930 analyzer.Hsc concluded that the investigation of the event is consistent with a contaminated well of co2_c reagent, which generated an inaccurate lot calibration, and the source of the contamination is unknown.The cause of the event is unknown.The analyzer is fully operational.The device is performing within specifications.No further evaluation is required.
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