Model Number 72081-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Nausea (1970); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
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Event Date 01/09/2024 |
Event Type
Injury
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Event Description
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A customer reported a ¿scan again in 10 minutes¿ error message with the adc device and was unable to obtain readings.As a result, the customer experienced symptoms described as nausea, tremor, confusion, and was unable to self-treat.Customer had contact with a non-healthcare professional third-party who provided baqsimi (glucagon) nasal spray as treatment.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 manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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 for this complaint.An extended investigation has been performed for the reported complaint.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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Manufacturer Narrative
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Sensor (b)(6) was returned and investigated.Visual inspection was performed on the returned sensor patch, no issues were observed.Data was extracted using approved software, and extraction was successful.The sensor was found to be in sensor state 6 (indicating early termination).No abnormalities were observed with the sensors data.Therefore issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported a ¿scan again in 10 minutes¿ error message with the adc device and was unable to obtain readings.As a result, the customer experienced symptoms described as nausea, tremor, confusion, and was unable to self-treat.Customer had contact with a non-healthcare professional third-party who provided baqsimi (glucagon) nasal spray as treatment.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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