Model Number 75175-84 |
Device Problems
No Device Output (1435); Unable to Obtain Readings (1516)
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Patient Problems
Hyperglycemia (1905); Dizziness (2194)
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Event Date 10/07/2022 |
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 libre reader were reviewed and the dhrs showed the libre reader 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 medical event due to not receiving their replacement adc device.Initially, a caller reported a port issue where the meter would only power on when the button is pressed but not when the strip is inserted.A replacement device was ordered.However; the replacement was not received and the customer was unable to monitor his blood glucose.Consequently, the customer experienced dizziness and required treatment of insulin (type/dose unknown) by a non-healthcare professional.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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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 freestyle optium neo meter were 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.This serves as a correction report.Section h10-additional mfg narrative updated:.
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Search Alerts/Recalls
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