Catalog Number 05021537001 |
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 08/17/2022 |
Event Type
malfunction
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Event Description
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We received an allegation of a display issue with 3 coaguchek xs meters.This mdr is for meter #2.The meter has black lines on the screen.The reporter described the screen as "similar to an old tv".It was verified that the lines would interfere with the interpretation of results.No misinterpretation of results was reported.Refer to mdr with patient identifier (b)(6) for the investigation of meter #1 and mdr with patient identifier (b)(6) for the investigation of meter #3.
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Manufacturer Narrative
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The meter was requested for investigation.A replacement meter was sent to the customer.
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Manufacturer Narrative
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The product was not submitted for investigation.If the product is returned in the future, a follow-up report will be submitted.
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Search Alerts/Recalls
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