Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Hot Flashes/Flushes (2153); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 11/28/2023 |
Event Type
Injury
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Event Description
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An alarm issue was reported with the adc device.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced loss of consciousness, seizure, hot flashes and reported a fall and was unable to self-treat, requiring treatment of orange juice by third-party.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 disconnected, faulty or damaged components, 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.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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.The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) 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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An alarm issue was reported with the adc device.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced loss of consciousness, seizure, hot flashes and reported a fall and was unable to self-treat, requiring treatment of orange juice by third-party.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 was 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.The sensor was activated with a known good reader and an error message was observed.Unable to perform linearity test.An visual inspection has been performed on the returned sensor and no issues were observed.Ble (bluetooth) functionality test was performed to check the bluetooth signal connection strength by scanning and pairing the returned sensor with a known good reader.No error message was observed.Error message observed in previous investigation is the result of using the incorrect reader configuration with the returned sensor.Sensor data was extracted and reviewed.First 5 ble packets were transfer successfully indicates that the signal connection is functional and no signal loss message was observed.Therefore, this 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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