Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Numbness (2415); Loss of consciousness (2418)
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Event Date 08/02/2023 |
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 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 customer reported receiving lower readings from the adc device compared to a competitor brand meter.The customer experienced "fainting and numbness of the tongue." as a result, the customer required third-party treatment of "something to drink." there was no report of death or permanent impairment associated with this event.
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Event Description
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A customer reported receiving lower readings from the adc device compared to a competitor brand meter.The customer experienced "fainting and numbness of the tongue." as a result, the customer required third-party treatment of "something to drink." there was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs(device history review) 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.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.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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