The information in this report is from a voluntary event report the customer submitted directly to fda.The manufacturer does not have any customer contact information.The customer complained of results displayed on the coaguchek xs meter with an unknown serial number with a "c" beneath the result.A fingerstick result was obtained on a patient in a physician office.The actual result was not provided.A staff person noted the small "c" below the result but was unable to find anything in the operator manual or the package insert addressing this.The customer called the manufacturer to determine the meaning of the "c" beneath the result.The customer was informed that the "c" result meant the result was invalid.The customer alleges that if they had not called to find out the result was invalid, the invalid result would have been reported and acted upon.No adverse event occurred.The manufacturer faxed the customer a letter dated 2011 explaining the factors that could cause the "c" to occur.The customer indicates they received their meter in 2015 and the user manual is dated 2013, however, the user manual had not been updated to reflect the advisory letter that was sent in 2011.The investigation by the manufacturer has determined that the instructions for the "c" flag issue are currently present in the coaguchek xs plus and coaguchek xs pro user manuals.The patient self testing coaguchek xs user manual has been updated with instructions regarding the "c" flag issue.The professional coaguchek xs user manual is currently being revised with instructions for the "c" flag issue.
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