The initial reporter stated they received questionable results for one patient sample tested with lipc (lipase) on a cobas pro c 503 analytical unit.On (b)(6) 2023, a first sample collected from the patient resulted in a lipase value of 25 u/l.On (b)(6) 2023, a second sample was collected from the patient and resulted in a lipase value of 698 u/l.On (b)(6) 2023, a third sample was collected from the patient and resulted in a lipase value of 22 u/l.The result from the second sample was questioned as an increase of 698 u/l would not be expected based on the lower results received on (b)(6) 2023 and (b)(6) 2023.The second sample was repeated, resulting in a lipase value of 713 u/l.This sample was also repeated on a second analyzer, resulting in a lipase value of 768 u/l.
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Calibration and controls recovered within specifications.A sample from the patient was provided for investigation and the result obtained by the customer could be reproduced.In the absence of detailed information about the patient, including diagnosis and medical history, no definitive assessment could be made as to the cause of the elevated results.Based on the immunoglobulin results of the sample obtained during the investigation an interference due to gammopathy can be ruled out.In rare cases, gullo syndrome: benign pancreatic hyperenzymemia, could be present.This is an identified syndrome characterized by an abnormal increase in serum pancreatic enzymes in the absence of pancreatic disease.Strong fluctuations within a very short time are possible.
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