Model Number XS PST |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/03/2022 |
Event Type
malfunction
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Event Description
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Customer is reporting a display issue with coaguchek xs meter serial number (b)(4).The customer stated the display has faded spots.Customer states the results field is not missing segments but the segments are faded.Customer did not report any misinterpretation of results.
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Manufacturer Narrative
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Occupation is patient/consumer.Meter was requested for return and the investigation is ongoing.
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Manufacturer Narrative
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The meter was returned for investigation.The device did not turn on during investigation, therefore the error log could not be read out.The optical inspection of the printed circuit board revealed contamination due to residues of fluid ingress.The contamination on the battery contacts caused a power interruption.Therefore it is not possible to turn the meter on.The contamination can lead to the mentioned problem with the faded/ missing segments.This malfunction is related to a user error.Medwatch fields d9 and h3 have been updated.
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Search Alerts/Recalls
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