Model Number 393-090 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
Death (1802)
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Event Date 04/04/2017 |
Event Type
Death
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Event Description
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According to the complaint, a (b)(6) male, who presented with severe metabolic acidosis, passed away in the emergency department.The hospital has raised concerns regarding the measurements done on the abl90 analyzer.The hospital also claims that reporting of very abnormal results on the printed reports is not clear and in this case contributed to a critical result being missed by the caregiver.
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Manufacturer Narrative
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The investigation of the analyzer data logs, analyzer printouts and additional information from the customer is ongoing.New data logs have been received and are currently under evaluation.The investigation has shown, that all patient results are flagged and reported on the analyzer printout according to specifications given in the product instructions for use and the user defined settings of reportable range.The customer has expressed a wish to have the icons on the printout printed in color.Unfortunately, radiometer is currently unable to accommodate this, as the printer is only able to print in black.Radiometer is in dialogue with the customer.
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Manufacturer Narrative
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The data logs have been investigated with the following results: - no evidence of any electronic, mechanically, sensor cassette or solution pack errors was found.- no evidence of any problem with chloride results was found.The reasons for the increase in chloride concentration in the later results is an increased concentration of chloride in the sample and the chloride level follow the sodium level.- comparison of results from the same analyzer but from a different patient also indicates that the chloride results follow the sample.- all patient results are flagged and reported on the analyzer printout according to specifications given in the product instructions for use and the user defined settings of reportable range.
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Search Alerts/Recalls
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