Catalog Number 03666794001 |
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 10/28/2022 |
Event Type
malfunction
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Event Description
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There was an allegation of intermittent display issues with a coaguchek xs meter.The customer stated the batteries may have been installed incorrectly.When the meter was powered on the results field displayed "88.1." instead of the correct display of "88.8." upon completion of a display check, the results field correctly displayed "88.8." the meter settings were reviewed and the meter was turned off.When the meter was powered back on the results field displayed "18.8." the meter memory was reviewed and the results field was complete.After the initial point of contact, the customer replaced the batteries and requested assistance resetting the meter.The reporter stated there were no display issues with this set of batteries.Upon completion of a display check, the results field correctly displayed "88.8." there were no missing segments.The meter memory was reviewed and there were no missing segments.The meter was powered on and "88.8" appeared correctly.The meter was powered on by inserting a test strip and the code number displayed correctly with no missing segments.
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Manufacturer Narrative
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Reporter occupation is patient/consumer.The meter was requested for investigation.The investigation is ongoing.
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Manufacturer Narrative
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The meter was received for investigation.The circuit board was contaminated by penetrated liquid.This contamination affects the conductive rubber contacts on the circuit board.Upon turning on the meter, missing segments were observed.Missing segments were shown clearly when confirming the code number, the countdown for blood application, and the meter result.No plausible results were displayed.The investigation determined the root cause of the issue was contamination of the contacts due to improper handling or maintenance by the customer.
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Search Alerts/Recalls
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