Model Number 71953-01 |
Device Problem
Failure to Power Up (1476)
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Patient Problems
Hypoglycemia (1912); Tachycardia (2095)
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Event Date 11/06/2023 |
Event Type
Injury
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Event Description
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A customer reported the adc device would not power on with the button pressed or test strips inserted.The customer could not obtain blood glucose readings and as a result, they became hypoglycemic and experienced palpitations.The customer had contact with a healthcare professional who treated the customer with sugar water at 5:15 pm and oral glucose at 6 pm.No further information was reported.There was no report of death or permanent injury associated with this event.
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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 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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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.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.If the product is returned, a physical investigation will be performed and a follow-up report submitted.This serves as a correction report.Section h10 (additional mfg narrative ) was incorrectly submitted in the initial report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported the adc device would not power on with the button pressed or test strips inserted.The customer could not obtain blood glucose readings and as a result, they became hypoglycemic and experienced palpitations.The customer had contact with a healthcare professional who treated the customer with sugar water at 5:15 pm and oral glucose at 6 pm.No further information was reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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