At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the freestyle freedom lite meter and freestyle strips were reviewed, and the dhrs showed the freestyle freedom lite meter and freestyle strips passed all tests prior to release.Retain testing was performed for freestyle strips and all units performed within specification.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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A customer reported that the test would not start with the adc device, after applying sample.The customer indicated requiring third-party treatment due to this issue, but refused to continue troubleshooting.There was no report of death or permanent injury associated with this event.
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