Model Number 72081-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Hyperglycemia (1905); Blurred Vision (2137); Shaking/Tremors (2515); Convulsion/Seizure (4406)
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Event Date 12/01/2023 |
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.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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A low readings issue with the adc device was reported.Customer received lower sensor scan results compared to readings obtained on a competitor brand device and experienced shakiness, blurred vision and seizures.The customer had contact with a healthcare professional (hcp) who checked the customer¿s blood sugar.The customer reportedly self-treated with liprolog 5 units every hour, magnesium and electrolytes.Additionally, the hcp recommended hospital admittance.However, the customer declined this recommendation.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
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Event Description
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A low readings issue with the adc device was reported.Customer received lower sensor scan results compared to readings obtained on a competitor brand device and experienced shakiness, blurred vision and seizures.The customer had contact with a healthcare professional (hcp) who checked the customer¿s blood sugar.The customer reportedly self-treated with liprolog 5 units every hour, magnesium and electrolytes.Additionally, the hcp recommended hospital admittance.However, the customer declined this recommendation.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Additional investigation information has been conducted.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 was found to be in 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.The passing of functionality testing is an indication that there were no issues with sensor functionality and electronics, therefore this issue is not confirmed.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.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 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 low readings issue with the adc device was reported.Customer received lower sensor scan results compared to readings obtained on a competitor brand device and experienced shakiness, blurred vision and seizures.The customer had contact with a healthcare professional (hcp) who checked the customer¿s blood sugar.The customer reportedly self-treated with liprolog 5 units every hour, magnesium and electrolytes.Additionally, the hcp recommended hospital admittance.However, the customer declined this recommendation.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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