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 07/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation is lay user/patient.The meter was requested for investigation.
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Event Description
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The initial reporter complained of a display issue with a coaguchek xs meter.The reporter stated when a test strip was inserted into the meter the code number of "419" displayed as "417." the code number is made up from the results field segments.The issue with the code number could impact the interpretation of results.The code key was removed and checked; the code number on the code key was "419." a display check was performed and all segments in the results field were complete.The reporter inserted another test strip into the meter and the code number displayed as "419" correctly.
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Manufacturer Narrative
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The customer's meter was received for investigation.The display showed no issues during the investigation the device has been disassembled and its electronic compartment has been visually inspected.No contamination or other abnormalities are visible.No root cause or any other evidence for missing segments were found.The mentioned problem could not be reproduced.Medwatch fields d10 and h3 were updated.
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Search Alerts/Recalls
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