The customer reported to siemens that the specimen ran using posbcombo panel type 20 and resulted on (b)(6) 2014 was identified as listeria monocytogenes and labpro (version 4.11) did not transmit the results to the laboratory information system (lis).The customer was concerned that there was a delay in treatment and delay in reporting to the cdc (results of listeria monocytogenes).Further confirmation with the customer indicates that the lab manager was not informed by the lab personnel of the specimen results until (b)(6) 2014 and therefore based on their procedure, it resulted in the delay in reporting to cdc which is a requirement by the arkansas department of health.On (b)(6) 2014, the customer reported to siemens that the patient passed away on (b)(6) 2014.Also noted on this date was possible mis-identification.Information about the patient treatment and/or cause of death was not provided.The specimen was sent to the state lab and to quest for id confirmation.The customer informed siemens of the quest results on (b)(6) 2014, indicating that the id should be an actinomyces species.After listeria was originally reported on (b)(6) 2014, the patient was placed on ampicillin and gentamicin.The nurse indicates there was no change in condition after being placed on this treatment.After further discussion with the listeria mis identification with the customer, the customer indicates that this is an identification that she never reported before but since (b)(6), she has reported 3 to the state.
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The device was not returned for evaluation.The configuration report sent by the customer and reviewed by siemens headquarter support center (hsc) revealed the customer's laboratory information system (lis) device is not set up for auto-transmission, therefore, transmission of results would be manual.The lis is also not setup to any transmission filters.Based on the provided log files, there was no objective evidence of delay in transmission of the results from labpro.The labpro interface log of the specimen number provided by the customer shows that on (b)(6) 2014, this specimen was transmitted multiple times without error.Information about the patient treatment and/or cause of death was not provided.
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