Catalog Number 10379677 |
Device Problems
Device Markings/Labelling Problem (2911); Patient Data Problem (3197)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/14/2014 |
Event Type
malfunction
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Event Description
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Customer reported incorrect patient id on instrument when barcode label was scanned.There was no report of injury due to this event.
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Manufacturer Narrative
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After going through other patient results, the customer reported the incorrect patient id due to operator error.Cause was due to the patient id barcode not being scanned properly by the operator.Instrument is working as intended.
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Manufacturer Narrative
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Initial mdr # 1217157-2014-00051 was filed with the fda on 04/07/14.
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Manufacturer Narrative
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Correction: cause was not due to the incorrect barcode being scanned, this issue is due to operator error.The error was incorrect selection of information on the instrument.
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Search Alerts/Recalls
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