Model Number 71940-01 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Fatigue (1849); Hypoglycemia (1912); Nausea (1970); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)
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Event Date 12/02/2022 |
Event Type
Injury
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Event Description
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A bent sensor tip was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced hypoglycemia, nausea, fatigue, and loss of consciousness.In addition, the customer reported being very thirsty and had to ¿pee really bad as well¿.The customer was unable to self-treat and had contact with a healthcare professional (hcp) who administered intravenous glucose and unspecified oral medication to the customer for a diagnosis of diabetic ketoacidosis (dka).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.At this time product has not yet been returned.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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.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 the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and 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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Event Description
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A bent sensor tip was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced hypoglycemia, nausea, fatigue, and loss of consciousness.In addition, the customer reported being very thirsty and had to ¿pee really bad as well¿.The customer was unable to self-treat and had contact with a healthcare professional (hcp) who administered intravenous glucose and unspecified oral medication to the customer for a diagnosis of diabetic ketoacidosis (dka).There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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