Model Number 71992-01 |
Device Problem
Failure to Fire (2610)
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Patient Problems
Vomiting (2144); Dizziness (2194)
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Event Date 07/28/2023 |
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.The device manufacturing date is unknown.The date entered in section h4 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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Event Description
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The customer reported attempting to apply an adc device and being unsuccessful due to the inserter not firing and, as a result, being unable to monitor glucose levels.The customer felt a rise in blood glucose, vomiting, and dizziness.The patient was admitted to the hospital and was under observation for two days.The patient was provided with a serum (type/dose unspecified).No other information was provided.There was no report of death or permanent impairment associated with this event.
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Event Description
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The customer reported attempting to apply an adc device and being unsuccessful due to the inserter not firing and, as a result, being unable to monitor glucose levels.The customer felt a rise in blood glucose, vomiting, and dizziness.The patient was admitted to the hospital and was under observation for two days.The patient was provided with a serum (type/dose unspecified).No other information was provided.There was no report of death or permanent impairment 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.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 libre sensor kits were reviewed and the dhrs showed the libre sensor kits 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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Search Alerts/Recalls
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