DIMENSION VISTA? DIMENSION VISTA 1500 INTERNATIONAL 10444802

[59046803] Analysis of the instrument data provided indicates that the cause for the falsely depressed crp results is user error. The customer contacted the siemens customer care center to discuss the issue. The customer complained that qc and patient results for crp were 1/10th of the expected crp concentrations. For an unknown reason, on 2016-07-21, the method was calibrated by using the prot2 cal calibrator (lot: 5mc001) with calibrator concentrations 1/10th of the than expected values. From that calibration all qc and patient samples run until 2016-09-20, a total of 2364 patient results, were reported with a falsely low concentrations of 1/10th the correct value. Once they have realized their error, the results have been corrected. Siemens completed an investigation of the incident and concluded it to be a user error. The bottle value for the calibrator was manually changed by the user from 2. 12 from to 0. 212 mg/dl, resulting in the lower than expected results. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10

[59046804] Falsely depressed c-reactive protein (crp) results were obtained on qc and patient samples on the dimension vista 1500 instrument. A total of 2,364 patient results were reported to physicians during a period from 2016-07-21 through 2016-09-20 during which a user error during method calibration had impacted results. Patient results were questioned by physicians. The account repeated samples after the error was corrected. Corrected results were reported. There is no indication that patient treatment was altered or prescribed on the basis of the falsely depressed crp results. There was no report of adverse health consequences as a result of the falsely depressed crp results.
Patient Sequence No: 1, Text Type: D, B5