Model Number 71953-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hyperglycemia (1905); Vomiting (2144); Diabetic Ketoacidosis (2364)
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Event Date 10/30/2023 |
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 mfg 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 error message was reported with the adc device.Customer received an error 3 message on their meter display and was unable to obtain readings.As a result, customer experienced "vomit and ketonemia" and was administered a insulin injection by a healthcare professional.There was no report of death or permanent impairment associated with this event.
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Event Description
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An error message was reported with the adc device.Customer received an error 3 message on their meter display and was unable to obtain readings.As a result, customer experienced "vomit and ketonemia" and was administered a insulin injection by a healthcare professional.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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhr(device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.Dhrs for the precision strips were reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing was performed for precision strips, and all units performed in specification and passed.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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