Model Number B221 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The event occurred in (b)(6).
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Event Description
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The customer complained of a barcode reading error on a cobas b 221<4>roche omni s4 system that could potentially impact patient results, interpretation of patient results, or patient identification.The customer stated that random order id alphabetical letters were changing from a capital letter to lower case letters.There was no allegation of any patient identifications being misinterpreted.There was no allegation of an adverse event.The barcode scanner was reprogrammed but the issue remained.The barcode scanner was replaced and the issue was resolved.The barcode scanner causing the issue was requested for further investigation.
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Manufacturer Narrative
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The barcode scanner causing the issue is a datalogic touch90 with serial number (b)(4) , model:td1100, class:td1170-bk-90.This handheld barcode scanner was returned for investigation with no visual damages.The returned meter was installed and tested on a retention cobas 221.Barcode label format code 128 was under to reproduce the barcodes used at the customer site.The customer¿s allegations were not reproduced.The investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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