Model Number 71940-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Pain (1994); Tachycardia (2095); Diabetic Ketoacidosis (2364); Polydipsia (2604)
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Event Date 05/03/2022 |
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 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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Event Description
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An error message was reported with the adc device.Customer received a "sensor not working" message and was unable to obtain readings.As a result, customer experienced symptoms described as pain in stomach, chest palpitations, and thirst and was able to self-treat.It was also reported that customer had contact with hcp and received was given treatment of iv insulin and "solutions" for diagnosis of diabetic ketoacidosis (dka).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.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 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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An error message was reported with the adc device.Customer received a "sensor not working" message and was unable to obtain readings.As a result, customer experienced symptoms described as pain in stomach, chest palpitations, and thirst and was able to self-treat.It was also reported that customer had contact with hcp and received was given treatment of iv insulin and "solutions" for diagnosis of diabetic ketoacidosis (dka).There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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