Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Tachycardia (2095); Loss of consciousness (2418); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)
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Event Date 11/29/2023 |
Event Type
Injury
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Manufacturer Narrative
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At this time, product has not yet 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 record) 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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Event Description
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A customer received a "replace sensor" error message with the adc device and was unable to obtain readings.As a result, customer experienced symptoms described as heart racing, shortness of breath, gets disoriented, a seizure, a loss of consciousness, and reported being unable to self-treat.However, no contact with a healthcare professional (hcp) or non-hcp third-party intervention was reported for this issue.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 received a "replace sensor" error message with the adc device and was unable to obtain readings.As a result, customer experienced symptoms described as heart racing, shortness of breath, gets disoriented, a seizure, a loss of consciousness, and reported being unable to self-treat.However, no contact with a healthcare professional (hcp) or non-hcp third-party intervention was reported for this issue.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 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.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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