The initial reporter stated they received questionable results for one patient sample tested with amylase (amyl2) on a cobas 8000 c 502 module (serial number unknown) and a cobas 6000 c (501) module (serial number (b)(4)).The results did not agree with the clinical status of the patient.The sample initially resulted in an amylase value of 460 u/l on the c 502 analyzer.Since the laboratory had no historical data from this patient, the initial value was reported outside of the laboratory to the patient.The patient's doctor asked the laboratory to repeat the sample since the result did not match the patient's clinical status.According to the patient's doctor, the patient had no pathologies.The complained sample was then repeated on the c 501 analyzer (b)(6) 2022.Resulting in an amylase value of 468 u/l.A second sample was also collected from the patient and tested (b)(6) 2022.Resulting in an amylase value of 53 u/l.
|
The second sample collected from the patient resulted in the following relevant test results: alb = 44.4 g/dl, ua = 3.2 mg/dl, bild = 0.1 mg/dl, bilt3 = 0.3 mg/dl, ca = 9.3 mg/dl, cho = 202 mg/dl, crej = 0.88 mg/dl, crp = 0.11 mg/dl, iron = 98 ug/dl, ggt = 18 u/l, gluc = 79 (no units provided), lip = 40 u/l, alt = 12 u/l, trigl = 128 mg/dl, tp = 6.6 g/dl, alp = 141 (no units provided), hdl = 81.2 mg/dl.
|
Quality control data was acceptable.The first three calibrations performed with the used reagent lot failed, but the fourth calibration performed was valid.A general reagent or hardware issue could be excluded.The maximum daily dose of the ancoron and lamotrigine medications the patient was taking could cause interference with the amylase assay.None of these drugs are suitable for acute therapy and must be taken long-term.When taken as tablets, a sharply rising plasma level in the short term is not to be expected.The investigation could not identify a product problem.The cause of the event could not be determined.
|