Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Muscle Weakness (1967); Dizziness (2194)
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Event Date 08/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.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 customer reported via webform that they received a sensor error message with the adc device.The customer was contacted and further reported that they felt hypoglycemic with symptoms of dizziness, loss of strength, and required treatment of glucose from a third-party.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer reported via webform that they received a sensor error message with the adc device.The customer was contacted and further reported that they felt hypoglycemic with symptoms of dizziness, loss of strength, and required treatment of glucose from a third-party.There was no report of death or permanent injury 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.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.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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 was properly seated, and no physical damage was observed on the returned sensor patch.Data was extracted from the returned sensor patch using approved software.The sensor was found to be in sensor state 6 (indicating abnormal termination) with a brownout reset event internally logged (event 21).Visual inspection was performed on the sensor plug and no failure modes were observed.The returned sensor was sent for further investigation and de-cased.Visual inspection was performed on the pcba (printed circuit board assembly) and no issues were observed.An extended investigation has also been performed on the returned puck and no issues were observed.The battery was measured, and the results were within specification.Therefore, this issue is confirmed to brownout reset.All pertinent information available to abbott diabetes care has been submitted.Additional info: added:d4 - unique identifier (udi) # (b)(4).
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Event Description
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A customer reported via webform that they received a sensor error message with the adc device.The customer was contacted and further reported that they felt hypoglycemic with symptoms of dizziness, loss of strength, and required treatment of glucose from a third-party.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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