Model Number DIMENSION VISTA 1500 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to the customer site.The cse analyzed the instrument and replaced the s1 belt, the s2 belt, probes and a vertical motor.Verification of tbil recovery by running 400 complete metabolic panels (cmp) with repeats on any tbil over 0.8 from the aliquot plate.All results are well within manufactures specification.The instrument is performing according to specifications.The cause of the discordant tbil results is unknown.No further action required.No further evaluation of this device is required.
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Event Description
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The customer stated that at least 70 discrepant, falsely elevated total bilirubin (tbil) results were obtained on a dimension vista 1500 instrument.The initial results were reported to the physician.The physician did not question the results.The tests were repeated on an alternate dimension vista 1500 and the results were lower.The repeated results were reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated total bilirubin results.
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Search Alerts/Recalls
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