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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Manufacturer Narrative
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The meter was requested for investigation.A replacement meter was sent to the customer.
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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 #1.The meter would power on, briefly flash a white screen, and then a black screen.No misinterpretation of results was reported.Refer to mdr with - patient identifier (b)(6) for the investigation of meter #2 and mdr - patient identifier (b)(6) for the investigation of meter #3.
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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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