Catalog Number 05021537001 |
Device Problems
Image Display Error/Artifact (1304); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The meter has been requested for investigation.The meter has not been received at this time.If the meter is returned in the future, a follow-up report will be submitted.
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Event Description
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We received an allegation about a dark screen on a coaguchek xs plus meter.It was reported that the meter screen is too dark to clearly read or interpret the results.The screen contrast was increased from 8 to 10 but is still too dark to read.When the meter is placed into the base unit, the results are still uploaded to the dms system.No results have been misinterpreted due to the dark screen.
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Manufacturer Narrative
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Fields d9 and h3 were updated.The meter was provided for investigation.The investigation found that the meter display has the same contrast and sharpness as a comparison device.The results are displayed normally and misinterpretation is not possible.There are no traces of an obvious mechanical impact visible on the housing of the device.The device was disassembled for further investigations of the electronic parts.The visual inspection of the electronic parts showed no abnormalities and no contamination was found.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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