Model Number 71953-01 |
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 09/18/2023 |
Event Type
Injury
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Event Description
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An error message was reported with the adc device.The customer was unable to obtain readings due to receiving an error 7 message, experienced "ketone levels rise up" and was unable to self-treat.The customer had contact with a healthcare professional who administered unspecified intravenous fluids (including saline) for treatment for the 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.A follow-up report will be submitted once additional information is obtained.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 and a valid serial number of reader 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.A tripped trend review was conducted for the reported complaint and libre reader, 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 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.Upon extended investigation, it was determined that the serial number provided by the customer (b)(6) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.
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Event Description
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An error message was reported with the adc device.The customer was unable to obtain readings due to receiving an error 7 message, experienced "ketone levels rise up" and was unable to self-treat.The customer had contact with a healthcare professional who administered unspecified intravenous fluids (including saline) for treatment for the 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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