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 05/21/2023 |
Event Type
Injury
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Manufacturer Narrative
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At this time, no product has been returned and a valid serial number has not been provided.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and fs libre sensors, 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.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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A "replace sensor" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced diabetic ketoacidosis and an inability to talk and was unable to self-treat, requiring administration of intravenous insulin and "fluid" by a hcp for treatment.No further treatment was indicated.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.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the previous report.Correction has been made.
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Event Description
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A "replace sensor" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced diabetic ketoacidosis and an inability to talk and was unable to self-treat, requiring administration of intravenous insulin and "fluid" by a hcp for treatment.No further treatment was indicated.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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