Model Number 71953-01 |
Device Problem
No Device Output (1435)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 06/24/2023 |
Event Type
Injury
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Event Description
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A testing issue was reported with the abbott diabetes care (adc) reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness and was unable to self-treat, requiring contact with emergency services (es).Upon arrival, an es healthcare professional provided glucagon (subcutaneously) (dose unspecified), "glass of juice, and bread" for a diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
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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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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 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 testing issue was reported with the abbott diabetes care (adc) reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness and was unable to self-treat, requiring contact with emergency services (es).Upon arrival, an es healthcare professional provided glucagon (subcutaneously) (dose unspecified), "glass of juice, and bread" for a diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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