Model Number 71992-01 |
Device Problems
Device Alarm System (1012); Application Program Problem (2880)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 08/13/2023 |
Event Type
Injury
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Event Description
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An alarm issue was reported with the adc device in use with an iphone 14 phone with ios operating system version 21017653.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a loss of consciousness and no third-party treatment was reported.No further information was provided by customer.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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The most probable root causes associated with this failure mode are software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.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 review) for the libre sensor and libre sensor kit 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 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).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Low glucose alarms were successfully activated.Issue is therefore not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An alarm issue was reported with the adc device in use with an iphone 14 phone with ios operating system version 21017653.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a loss of consciousness and no third-party treatment was reported.No further information was provided by customer.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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The freestyle librelink complaint investigated and determined that there were no issues with the librelink application that would have led to the complaint.The user reported missing low alarms.Attempted to recreate the user complaint and was not able to reproduce the complaint.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).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The reported sensor was activated with a retained reader and linearity testing was performed, all results were within specification.Low glucose alarms were successfully activated.Issue is therefore not confirmed.This serves as a correction report.Section h10 (additional mfg narrative) was incorrectly documented in the previous reports.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An alarm issue was reported with the adc device in use with an iphone 14 phone with ios operating system version 16.6and app version 2.10.1.7653.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced a loss of consciousness and no third-party treatment was reported.No further information was provided by customer.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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