According to the complaint a customer called to report that after a potentially haemolysed sample had been run through the analyser they had four patient results which gave abnormally high electrolyte results, the values were: k - 7.1, 5.8, 6.3 & 8.0 mmol/l, na - 230, 224, 233 & 236 mmol/l, ca - 2.96, 2.45, 2.76 & 2.81 mmol/l,and cl - 107, 106, 105 & 104 mmol/l.Reference values for 2 patients patient 1: k 7.1 mmol/l discrepant , k 4.3 mmol/l comparison, na 230 mmol/l discrepant , na 131 mmol/l comparison, ca 2.96 mmol/l discrepant , ca 1.21 mmol/l comparison, cl 107 mmol/l discrepant ,and cl 102 mmol/l comparison.Patient 2: k 8.0 mmol/l discrepant , k 4.9 mmol/l comparison, na 236 mmol/l discrepant , na 135 mmol/l comparison, ca 2.81 mmol/l discrepant , ca 1.19 mmol/l comparison, cl 104 mmol/l discrepant ,and cl 98 mmol/l comparison.No reports of death or serious injury.
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Radiometer medical aps have concluded their investigation.Most likely a blood clot got lodged in vicinity of the ref sensor, which has disturbed the electrical signal between the ref and ca, k, na and ph sensors.Furthermore, presence of a clot likely has caused a dilution of blood samples with rinse solution in the ph/bg module, resulting in approx.6% higher cl readings compared to abl90.What was done to resolve the issue: comparison of the same samples on abl90, protein removal program performed, measuring chambers cleaned and checked, additional 2-point calibrations performed, additional qc performed.
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