Model Number XS PST |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer¿s products have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Occupation was lay user/patient.
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Event Description
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The initial reporter experienced an issue with the display of the coaguchek xs meter that could cause a misinterpretation of a result.The customer picked up the meter without turning it on and she could barely see three "8s" on the screen.The screen looked very dim without her pressing the power button.The customer received a battery error and the meter would not turn on.There was no actual misinterpretation of results.
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Manufacturer Narrative
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The customer's meter was received for investigation.The device could not be turned on.Device data and fault memory cannot be read out.The meter¿s circuit board was tested for damage or contamination and it was found that the battery compartment and printed circuit board were contaminated by liquid which has penetrated / corroded the contacts.The observed contamination can lead to the reported display issue.The root cause is determined to be contamination due to improper handling or maintenance by the customer.Medwatch fields d10 and h3 were updated.
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Search Alerts/Recalls
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