Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Hypoglycemia (1912); Nausea (1970); Pain (1994)
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Event Date 02/27/2024 |
Event Type
Injury
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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 and as a result the customer was unable to obtain readings and experienced sleepiness, nausea, pain in the stomach and felt unwell.The customer was unable to self-treat and received food (unspecified), grapes, apples and orange juice as treatment by spouse.There was no report of death or permanent impairment 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 reported product is not expected to be returned as reporter indicated the device was discarded.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 fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor kit passed all tests prior to release.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.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 (adc) has been submitted.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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 reported product is not expected to be returned as reporter indicated the device was discarded.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 fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor kit passed all tests prior to release.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.This serves as a correction report.Section h11 (addtl mfg narrative) was incorrectly documented in the previous report.Correction has been made.All pertinent information available to abbott diabetes care (adc) 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 and as a result the customer was unable to obtain readings and experienced sleepiness, nausea, pain in the stomach and felt unwell.The customer was unable to self-treat and received food (unspecified), grapes, apples and orange juice as treatment by spouse.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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