Model Number 71953-01 |
Device Problems
Unable to Obtain Readings (1516); Battery Problem (2885)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 02/08/2023 |
Event Type
Injury
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Event Description
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A battery/no power issue was reported with the adc device.Customer was unable to obtain readings due to the device not charging and ¿needing a new charging cable¿ and as a result, the customer experienced hypoglycemia with symptoms described as ¿feeling lightheaded¿ and a loss of consciousness.Customer had contact with a healthcare professional (hcp) and was treated with intravenous glucose for a diagnosis of hyperglycemia and also provided rifaximin (500 mg), and linagliptin (500 mg).There was no report of death or permanent impairment 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 date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered 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 and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and fs libre readers, no trends were identified that would indicate any product related issues.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 battery/no power issue was reported with the adc device.Customer was unable to obtain readings due to the device not charging and ¿needing a new charging cable¿ and as a result, the customer experienced hypoglycemia with symptoms described as ¿feeling lightheaded¿ and a loss of consciousness.Customer had contact with a healthcare professional (hcp) and was treated with intravenous glucose for a diagnosis of hyperglycemia and also provided rifaximin (500 mg), and linagliptin (500 mg).There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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