According to the complaint, a customer from a neonatal icu reports that an abl827 flex analyzer (754r0313n001) gave spurious results for the na+, ica2+ and to a lesser extent k+ parameter.The spurious results were obtained from 6 different patients that gave the following results: sample #: k+ 5.1, ca++ 1.33.Sample # (b)(6): na 148, ca 1.65.Sample # (b)(6): na 153, ca1.52.Sample # (b)(6): na 148, k 5.1, ca 1.43.Sample# (b)(6): k 5.5, ca 1.33.Sample # (b)(6): na 149, k 5.4, ca 1.55.The customer reports that the measured results did not correlate with the clinical status of the patients.Assuming all patients should be in normal range for the na, ca and k parameter it is assed that in a worst case scenario the discrepancies could lead to harm for the patients.None of the patients were impacted or injured due to this event.Patients are still on hospital ward undergoing ongoing treatment.No additional treatment were required as a consequence of this event.
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From the preliminary radiometer investigation it was found that the discrepant results were most likely due to the use of non-radiometer samplers.However, since the hospital solved the issue by replacing the abl800 flex with an abl90 flex analyser, radiometer can not obtain evidence for this and the root cause remains unknown.
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