Model Number 71992-01 |
Device Problem
High Readings (2459)
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Patient Problem
Loss of consciousness (2418)
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Event Date 12/01/2021 |
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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A high readings issue was reported with use of the adc freestyle libre 2 sensor.Customer received unspecified high sensor scan and self treated with insulin.Customer subsequently experienced a loss of consciousness and required treatment of unspecified iv provided by a healthcare provider.A reading of 106 mg/dl was obtained on the hcp meter post treatment.There was no report of death or permanent impairment associated with this event.
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Event Description
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A high readings issue was reported with use of the adc freestyle libre 2 sensor.Customer received unspecified high sensor scan and self treated with insulin.Customer subsequently experienced a loss of consciousness and required treatment of unspecified iv provided by a healthcare provider.A reading of 106 mg/dl was obtained on the hcp meter post treatment.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.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.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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Event Description
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A high readings issue was reported with use of the adc freestyle libre 2 sensor.Customer received unspecified high sensor scan and self treated with insulin.Customer subsequently experienced a loss of consciousness and required treatment of unspecified iv provided by a healthcare provider.A reading of 106 mg/dl was obtained on the hcp meter post treatment.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.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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