[400827]
In 05, bayer received a report of multiple discrepant results associated with digoxin, thcg, myoglobin, ckmb, troponin assays on the acs:180 se instrument. Investigation indicated that a lab technician performed some needed troubleshooting to clear a clog that was detected 2 days ago, as part of these activities the technician removed and replaced the sample aspirate probe tubing. The following day, the customer indicated that myoglobin results had been recovering lower than expected. In addition, the qc material was reported to be low or not recovering anything. Upon inspection the customer indicated that the smaple probe tubing had come off and there was water under the instrument. The following day bayer dispatched a field engineer to investigate, the field serivice engineer confirmed that the sample probe tubing had come off sometime after the technician's troubleshooting actions 2 days later. The tubing was appropriately reconnected and the system was tested, system was determined to tbe operational. Once the instrument was operational the laboratory issued a corrected report for the discrepant results. Although discrepant results were reported there in no evidence of patient interventions. Bayer's assessment of the event indicates that the customer maintenance documents available to troubleshoot the instrument are appropriate, the probe tubing connection design is robust and adequate warnings are in place to prevent this from reoccuring. In this particular case, the troubleshooting actions taken by the lab technician may have inappropriately reconnected or loosened the sample probe tubing which eventually came off causing the discrepant results. The qc material being under range gave indications that there was an issue with the instrument. Bayer instructions for use indicate that if the quality control materials do not fall within the bayer's expected valves or within the laboratory's expected values the operator should review the insructions for use to ensure the assay was performed according to the procedures recommended by bayer; verify that the materials are not expired; verify that required maintenance was performed and if necessary, rerun the quality control samples or contact bayer for more assistance. At this time bayer considers this to be an isolated event, and is reporting this under part 803 because were this event to reoccur there could be patient interventions that constitute a risk to health. For medical device reporting purposes this event is considered closed.
Patient Sequence No: 1, Text Type: D, B5