Model Number 98814-65 |
Device Problem
No Device Output (1435)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle optium neo meter was reviewed and the dhrs showed the freestyle optium neo meter passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported a delivery issue with a replacement adc device.The customer initially reported that the meter turns on with button but not with strips inserted, and so a replacement device was ordered.Due to a delivery issue, the customer was unable to monitor their glucose and was unable to self-treat due to unspecified symptoms.The customer had contact with a healthcare professional and received unspecified medical treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has 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 review) for the optium xceed meter was reviewed and the dhrs showed the optium xceed meter passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section h10 ( addtl mfg narrative ) was incorrectly documented in the initial final report no.1.The correct h10 ( addtl mfg narrative ) has been updated.
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Event Description
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A customer reported a delivery issue with a replacement adc device.The customer initially reported that the meter turns on with button but not with strips inserted, and so a replacement device was ordered.Due to a delivery issue, the customer was unable to monitor their glucose and was unable to self-treat due to unspecified symptoms.The customer had contact with a healthcare professional and received unspecified medical treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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