Model Number XS PST |
Device Problem
Circuit Failure (1089)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/08/2020 |
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 had an issue with the display of the coaguchek xs meter that could lead to a misinterpretation of results.After changing the batteries and performing a display check, the customer could see the display but it was extremely faded.He stated he could see the "888", but it was very faded.He could see other parts of the display as well but it was not a complete display.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 meter¿s circuit board was tested for damage or contamination and it was found the printed circuit board (pcb) was contaminated.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.Medwatch fields d9 and h3 were updated.
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Search Alerts/Recalls
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