Model Number 98814-65 |
Device Problem
No Device Output (1435)
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Patient Problems
Fall (1848); Hyperglycemia (1905); Dizziness (2194)
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Event Date 03/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A complaint was received reporting of not receiving a replacement adc meter, which was issued due to the customer's meter not starting after the blood sample was applied to the test strip.As a result, on (b)(6) 2022, the customer experienced dizziness and a fall.A healthcare provider was called to the customer's home.The customer was provided unspecified medical treatment by the healthcare provider for a diagnosis of hyperglycemia.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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Upon extended investigation, it was determined that the serial number provided by the customer (b)(6) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report and a valid serial number has not been provided.A tripped trend review was completed for the reported complaint and xceed meters, and there were no adverse trends that indicate any potential product related issues.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A complaint was received reporting of not receiving a replacement adc meter, which was issued due to the customer's meter not starting after the blood sample was applied to the test strip.As a result, on (b)(6) 2022, the customer experienced dizziness and a fall.A healthcare provider was called to the customer's home.The customer was provided unspecified medical treatment by the healthcare provider for a diagnosis of hyperglycemia.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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