Model Number 72081-01 |
Device Problem
High Readings (2459)
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Patient Problems
Hypoglycemia (1912); Nausea (1970); Dizziness (2194)
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Event Date 11/29/2023 |
Event Type
Injury
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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.At this time product has not yet been returned for this complaint.An extended investigation has been performed for the reported complaint.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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A high reading issue was reported with use of the adc device.The customer received a high sensor scan result of 143 mg/dl compared to a healthcare professional (hcp) meter and reported experiencing symptoms described as "nausea, dizziness, speech problems, difficulty concentrating," and was unable to self-treat.Customer had contact with both a non-hcp third-party and an hcp who obtained that blood glucose reading of 25 mg/dl and provided glucose as treatment.The results/comparison readings when plotted on a parkes error grid fall into the "d" zone, showing the difference in values to be clinically significant.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.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software and extraction was successful.Sensor state 7 with event log 11 and sensor state 8 with event log 9 are an indication that the sensor had terminated due to an error recognized by the sensor.This is a part of software design and is not an indication of product non-conformance.The watermark was observed at the base of the tail indicating the sensor being properly inserted.The returned sensor was further investigated and de-cased.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.Performed an smu (source measurement unit) test using connector key to ensure the sensor's electronics were functioning correctly and the returned unit did not have any glucose reading issues.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.Therefore, this 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 high reading issue was reported with use of the adc device.The customer received a high sensor scan result of 143 mg/dl compared to a healthcare professional (hcp) meter and reported experiencing symptoms described as "nausea, dizziness, speech problems, difficulty concentrating," and was unable to self-treat.Customer had contact with both a non-hcp third-party and an hcp who obtained that blood glucose reading of 25 mg/dl and provided glucose as treatment.The results/comparison readings when plotted on a parkes error grid fall into the "d" zone, showing the difference in values to be clinically significant.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.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software, and extraction was successful.The watermark was observed at the base of the tail indicating the sensor being properly inserted.The returned sensor was further investigated and de-cased.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.Performed an smu (source measurement unit) test with connector key to ensure the sensor's electronics were functioning correctly, and the returned unit did not have any glucose reading issues.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.Therefore, this 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 high reading issue was reported with use of the adc device.The customer received a high sensor scan result of 143 mg/dl compared to a healthcare professional (hcp) meter and reported experiencing symptoms described as "nausea, dizziness, speech problems, difficulty concentrating," and was unable to self-treat.Customer had contact with both a non-hcp third-party and an hcp who obtained that blood glucose reading of 25 mg/dl and provided glucose as treatment.The results/comparison readings when plotted on a parkes error grid fall into the "d" zone, showing the difference in values to be clinically significant.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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