Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Fatigue (1849); Hypoglycemia (1912); Nausea (1970)
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Event Date 11/16/2023 |
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.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.A customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced weakness, drowsiness, and nausea.The customer was unable to self-treat, requiring glucose from a third-party for treatment.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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An extended investigation has been performed for the reported complaint and it has been determined that there were no issues identified with the freestyle librelink application during replication that would have led to the reported issue.The customer reported signal loss.Attempted to replicate the customer's complaint using similar configurations samsung galaxy s20 fe 5g (android 13, 2.10.1.10406) and the reported issue was unable to be replicated and the system functioned as intended.If the product is returned, the case will be re-opened, and a physical investigation will be performed.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 in use with samsung galaxy m33 5g, os 13, app version 2.10.1.10406.A customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced weakness, drowsiness, and nausea.The customer was unable to self-treat, requiring glucose from a third-party for treatment.There was no report of death or permanent impairment associated with this event.
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Event Description
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An alarm issue was reported with the adc device in use with samsung galaxy m33 5g, os 13, app version 2.10.1.10406.A customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced weakness, drowsiness, and nausea.The customer was unable to self-treat, requiring glucose from a third-party for treatment.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.The sensor was found to be in 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 the bluetooth connection was successful.A linearity test was performed while the reader was wrapped in aluminum foil (to simulate signal loss), and signal loss message was observed.Sensor was scanned with reader to re-establish bluetooth connection and then was placed at a distance from the sensor.Signal loss message was not displayed.Therefore, the 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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The user reported signal loss.The reported issue was investigated and attempted to replicate.The reported configuration was not compatible with the freestyle librelink app.The latest revision of the compatibility guide was available to the customer on the abbott diabetes care website.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.This also serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the 1st follow up report.Correction has been made.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 in use with samsung galaxy m33 5g, os 13, app version 2.10.1.10406.A customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, the customer was not alerted of changes in glucose level and experienced weakness, drowsiness, and nausea.The customer was unable to self-treat, requiring glucose from a third-party for 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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