Mdr 2517506-2018-00395 was filed for the same event.The customer contacted the siemens customer care center (ccc) for the discordant, hb1c results obtained on the dimension exl system.Siemens headquarters support (hsc) reviewed the information provided and the cause of event was identified as use error for entering incorrect scaler units for hb1c lot ga8299.Hsc concluded that no product non-conformance was identified with the reagent and no product nonconformance was identified with the instrument.The incorrect scaler units were entered during a calibration which occurred on (b)(6) 2018.During the time period of (b)(6) 2018 to(b)(6) 2018, 859 patient results were reported.It is unknown if physicians questioned the results.There were 15 random patient samples processed again after recalibration on the same instrument at a later date, using the correct scaler % units and on an alternate instrument at an alternate facility obtaining the correct results.Based on the repeated results a letter was issued to all ordering physicians informing them of the possible bias.All 859 patient results were appended with the following statement to identify the bias: hba1c reported <7.0% negative bias of 0.3 -0.6%; hba1c reported between 7.0 - 9.0% no significant difference; hba1c reported > 9.0% positive bias of 0.5%.The device is operating within specifications.No further investigation is required.
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