Siemens has completed the investigation: the cause of the hemoglobin (hgb) discrepancy could not be determined from the information provided by the customer.The.Csv files are useful in verifying the sequence of analysis, as well as the other parameters that can be influenced as a result.However, the.Csv files were not helpful in determining the root cause for this event.Epoc calculated hgb is derived from the hematocrit (hct) reading on the epoc device.As per section 12.16.6 of the epoc system manual: "hemoglobin concentration is calculated from the measured hematocrit according to the relation: chgb (g/dl) = hct (decimal fraction) x 34." given this relation, the investigation focused on hct performance of the card lot 01-20215-40.A review of the in-house performance for the card lot 01-20215-40 did not identify any product deficiencies for hct.The failure rate of lot 01-20215-40 is not showing an increased trend in the field, therefore, there is no further evidence that the system or reagent cards are not performing as intended.From the information provided by the customer, there are a few factors that may have contributed to a discrepant hct reading.It is important to note that no repeat tests were performed for the discrepant epoc results.The patients underwent treatment between epoc and laboratory results, and therefore these hgb results cannot be compared directly.Sample handling (collection site, collection method) and testing delays are known to affect test results if proper precautions are not considered.The time between sample collection and analysis for all epoc and laboratory tests is unknown.Additionally, the customer did not know whether the arterial epoc samples were collected near a central line.Sample contamination/dilution can arise when samples are drawn from or near a central line.Increased hemodilution could lead to falsely low hematocrit and hemoglobin results.In addition, the samples were collected with unknown anticoagulant.Following epoc system manual section 12.2.6, samples should be collected exclusively with heparin as the anticoagulant.If no anticoagulant is used, the sample should be tested on epoc within 5 mins of collection.However, it is recommended that all samples are tested immediately.The choice of anticoagulant and time delay can have a significant effect on the epoc hematocrit and hemoglobin results.Based on the complaint and available information, the customer is not alleging that the device caused or contributed to the patient's death.The cause or date of death was not provided by the customer.
|