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 08/10/2020 |
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 stated segments were missing from the "three 8's" of the display of the coaguchek xs meter.This could lead to a misinterpretation of results.The customer did not attempt to test on the meter and there was no allegation of an actual result misinterpretation.
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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 by liquid.The root cause is determined to be contamination of the contacts due to improper handling or maintenance by the customer.
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Search Alerts/Recalls
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