Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Hyperglycemia (1905); Nausea (1970); Loss of consciousness (2418); Diaphoresis (2452)
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Event Date 11/18/2023 |
Event Type
Injury
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Event Description
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A low readings issue was reported with the adc device.Customer reported receiving unspecified low readings obtained on the adc sensor scan and stated the reading was lower than what was felt.As a result, the customer experienced hyperglycemia with symptoms described as nausea, sweating, and a loss of consciousness; however, after regaining consciousness the customer was able to self-treat with insulin provided by a non-hcp third-party.No further treatment was indicated.There was no report of death or permanent injury 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.The date of event is unknown.The date entered in section b3 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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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Sensor plug was not returned and no physical damage is 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).The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Issue was closed to no product returned.If the sensor plug 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 low readings issue was reported with the adc device.Customer reported receiving unspecified low readings obtained on the adc sensor scan and stated the reading was lower than what was felt.As a result, the customer experienced hyperglycemia with symptoms described as nausea, sweating, and a loss of consciousness; however, after regaining consciousness the customer was able to self-treat with insulin provided by a non-hcp third-party.No further treatment was indicated.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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