Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Vomiting (2144); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)
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Event Date 08/06/2023 |
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 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 low readings issue was reported with use of the adc device.Customer received unspecified low readings compared to readings obtained on a blood test and experienced a loss of consciousness and vomiting.Customer was hospitalized for the diagnosis of dka.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A low readings issue was reported with use of the adc device.Customer received unspecified low readings compared to readings obtained on a blood test and experienced a loss of consciousness and vomiting.Customer was hospitalized for the diagnosis of dka.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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