Model Number 71953-01 |
Device Problems
Unable to Obtain Readings (1516); Battery Problem (2885)
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Patient Problems
Skin Discoloration (2074); Loss of consciousness (2418)
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Event Date 03/05/2023 |
Event Type
Injury
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Event Description
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Customer reported her freestyle libre reader would only power on while connected to the data cable and was unable to obtain readings.Customer experienced "body started shutting down, skin color yellow, bloating" and a loss of consciousness.Customer was unable to self-treat, was treated with glucagon by a third-party.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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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg 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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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.Dhrs 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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Customer reported her freestyle libre reader would only power on while connected to the data cable and was unable to obtain readings.Customer experienced "body started shutting down, skin color yellow, bloating" and a loss of consciousness.Customer was unable to self-treat, was treated with glucagon by a third-party.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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