Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problem
Diabetic Ketoacidosis (2364)
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Event Date 07/24/2023 |
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 manufacturing 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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Event Description
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An unspecified error message was reported with the adc device and customer was unable to obtain readings.As a result, customer had to go to the pharmacy and get their glucose checked and then it was found that, they had diabetic ketoacidosis (dka).It is unknown if the customer received any medical treatment.No further details were provided and attempts to gather additional information were unsuccessful.There was no report of death or permanent injury 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.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs (device history review) showed the fs libre sensor and sensor kit passed all tests prior to release.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 ) and h4 (device mfg date) was incorrectly documented in the previous 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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An unspecified error message was reported with the adc device and customer was unable to obtain readings.As a result, customer had to go to the pharmacy and get their glucose checked and then it was found that, they had diabetic ketoacidosis (dka).It is unknown if the customer received any medical treatment.No further details were provided and attempts to gather additional information were unsuccessful.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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