Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Dehydration (1807); Diabetic Ketoacidosis (2364); Loss of consciousness (2418); Diaphoresis (2452)
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Event Date 09/29/2023 |
Event Type
Injury
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Event Description
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A "replace sensor" error message was reported with the adc device.The customer was therefore unable to obtain sensor readings.As a result, the customer experienced diabetic ketoacidosis with symptoms described as sweating, dehydration, and a loss of consciousness and was unable to self-treat.Customer presented at the hospital and, after a lab test result of 18.8 mmol/l was obtained, the customer was administered a "sliding scale of insulin" for treatment by a hcp.No further treatment was indicated.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.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.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle 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.All pertinent information available to abbott diabetes care has been submitted.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) and poise voltage testing were performed and all results were within specification.No malfunction or product deficiency was identified.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.The customer was therefore unable to obtain sensor readings.As a result, the customer experienced diabetic ketoacidosis with symptoms described as sweating, dehydration, and a loss of consciousness and was unable to self-treat.Customer presented at the hospital and, after a lab test result of 18.8 mmol/l was obtained, the customer was administered a "sliding scale of insulin" for treatment by a hcp.No further treatment was indicated.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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