Catalog Number 04837738001 |
Device Problems
Image Display Error/Artifact (1304); Misassembly by Users (3133)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2023 |
Event Type
malfunction
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Event Description
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We received an allegation about a faded display when a patient tested with a coaguchek xs meter.The reporter alleged that since the meter was flickering, he replaced the batteries.He also alleged that the meter did not power on after that.The reporter was advised to turn off the meter and press the m button to access the meter memory.The meter was powered on with an error message.The reporter alleged that he could not determine if the error message was an error 4 or an error 9 as the numbers were faded.
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Manufacturer Narrative
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The meter was requested for investigation.The reporter stated that the original batteries were not leaking.The investigation is ongoing.
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Manufacturer Narrative
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Sections d9 and h3 were updated.The meter was provided for investigation.The error log could not be read out as the device did not turn on during the investigation.The meter was disassembled for further investigation.The optical inspection of the printed circuit board revealed contamination due to residues of fluid ingress (leaked battery acid, cleaning solution).The residues are visible in the area on the printed circuit where communication with the display takes place.The contamination on the battery contacts led to the mentioned problem with the faded segments and was the cause of the power interruption.The investigation determined there was a user error.The root cause was due to contamination of the contacts due to improper handling or maintenance.
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Search Alerts/Recalls
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