[89465437]
The customer contacted the siemens customer care center (ccc). The customer's quality controls (qc) were within range on the day the event occurred. A siemens customer service engineer (cse) was dispatched to the customer site. After analyzing the instrument, the cse checked the mixers and replaced the sample probe 1 (s1) transducer. The cse aligned and primed s1, adjusted film height and top seal. The cse ran system check and qc, which passed. The cse performed a total service call. The cse reviewed the instrument data and determined that the reagent 1 and source lamp readings were deviating. There was no foaming on any probe. There were issued with cuvette manufacturing for calcium. Upon the cse specialist's recommendation, the customer made adjustment to the film height. The u-seal was new and the air pressure was acceptable. During a follow-up visits, the cse replaced the sample metering syringe and tubing and top seal solenoid. The cse primed all mechanisms and checked for bubbles and syringe gaps. The cse checked the mixers and ran system check, which passed. The cse adjusted the cuvette manufacturing and it was functioning properly. The cse replaced both solenoids as sample pump solenoid had failed. The cse repeated the test, ran system check and qc, which passed. The cse also replaced the solenoid valves for the sample probe and ran 10 samples from serum pool without high results. The cse ran a second group from serum pool with other samples mixed in with all panels, which were acceptable. The cse ran system check and qc, which passed. A total service visit was performed. The cause of the discordant, falsely elevated glu result on one patient sample is unknown. The instrument is performing according to specifications. No further evaluation of the device is required
Patient Sequence No: 1, Text Type: N, H10
[89465438]
A discordant, falsely elevated glucose (glu) result was obtained on a dimension exl 200 instrument. The discordant result was not reported to the physician(s). The sample was repeated on an alternate dimension exl instrument, resulting lower. It is unknown if the result from the alternate instrument was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated glu result.
Patient Sequence No: 1, Text Type: D, B5