Catalog Number 10282969 |
Device Problem
Incorrect Or Inadequate Test Results (2456)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/10/2014 |
Event Type
malfunction
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Event Description
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Customer reported discordant hemoglobin a1c(hba1c) results on the instrument.There was no report of injury due to this event.
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Manufacturer Narrative
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This event is in the process of being evaluated.The cause for the discordant hemoglobin a1c(hba1c) results is unknown.
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Manufacturer Narrative
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Customer indicated that precision study was performed and patient correlation was performed and they looked good.Customer indicated that they did not have results of precision or correlation study.Customer indicated that instrument is currently performing well and they are satisfied with instrument performance at this time.
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Search Alerts/Recalls
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