Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Fatigue (1849); Hyperglycemia (1905); Pain (1994); Dizziness (2194)
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Event Date 02/14/2024 |
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 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.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 it has been determined that there was no indication that the product did not meet specification.The device history records (dhrs) for the fs libre sensor kit were reviewed and the dhrs showed the fs libre 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 adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached after fourteen days or less of wear and the customer was unable to obtain readings or monitor glucose levels.As a result, the customer experienced "pain in fingers", "dizziness", "weakness", and was unable to self-treat, requiring third-party treatment of "dextrose" (type/dose unspecified) by a non-healthcare professional prior to going to the hospital.At the hospital, a healthcare professional provided unspecified third-party treatment for a diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.No physical damage was observed on the returned sensor patch and no issues were observed with the returned sensor adhesive.No malfunction or product deficiency has been identified.Therefore, the issue is not confirmed.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 kits were reviewed and the dhrs showed the libre sensor kits passed all tests prior to release.Section d4 (expiration date), d4 (unique identifier (udi)) and h4 (device mfg date) were updated based on returned product download.Section d4 (serial number) was updated from 3mh00w0wlw0 to 3mh00w0nlw0.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached after fourteen days or less of wear and the customer was unable to obtain readings or monitor glucose levels.As a result, the customer experienced "pain in fingers", "dizziness", "weakness", and was unable to self-treat, requiring third-party treatment of "dextrose" (type/dose unspecified) by a non-healthcare professional prior to going to the hospital.At the hospital, a healthcare professional provided unspecified third-party treatment for a diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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