The customer reported that they received questionable results for an unspecified number of samples tested for ion selective (ise) sodium on cobas b 123 analyzer serial number (b)(4).The analyzer was moved from one site to another with all consumables on board on (b)(6) 2015.The analyzer was powered off for approximately one hour.After moving the analyzer, the sensor did not settle, so it was replaced with sensor lot 21545185.Multiple calibrations were also performed after the relocation.The instrument sat unused for a while and it was then used side by side with an il gem4000 analyzer for a few days.The customer then noticed a discrepancy of 10 mmol/l between the analyzers for one patient sample tested for ise sodium on (b)(6) 2015.This sample was checked on other cobas b 123 analyzers and a siemens blood gas analyzer as well; results on these analyzers were as expected.It was stated that discrepancies were noticed on some other patient samples since this first one, but not all samples are affected.The customer noted that one level of control was within range, but higher than the usual running mean.The customer provided data for a total of eleven patient samples tested for multiple tests.Of the data provided, ten samples had erroneous results for ise sodium (na +), lactate (lac), partial pressure of oxygen (po2), and calcium (ca2+).Refer to the attached data for all patient results.The units of measure used for sodium were mmol/l.It was asked, but it is not known what units of measure were used for the lac, po2, and ca2+ tests.It was asked, but it is not known if any patient results were reported outside of the laboratory.The ten samples were tested on three different cobas b 123 analyzers; serial numbers (b)(4).The samples were also tested on a gem 4000 analyzer, architect analyzer, gem 3000 analyzer, and a radiometer abl 90 analyzer.This medwatch will refer to cobas b 123 analyzer serial number (b)(4).Patient identifier (b)(6) for information related to cobas b 123 analyzer serial number (b)(4).Refer to the medwatch with a1.Patient identifier (b)(6) for information related to cobas b 123 analyzer serial number (b)(4).It was asked, but it is not known if any patients were adversely affected due to the event.No adverse events were alleged.It was stated that the sensor lot number used on cobas b 123 analyzer serial number q413202 was (b)(4).The expiration date was asked for, but not provided.The sensor lot and expiration dates were asked for, but not provided for cobas b 123 analyzer serial numbers (b)(4).
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No adverse events occurred for this event.No erroneous results were reported outside of the laboratory and all results were used for evaluation purposes only.The following units of measure are used; lac is mmol/l, po2 is kpa, and ca2+ is mmol/l.The date received by the manufacturer was (b)(4) 2015.(b)(4).
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