Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Headache (1880); Blurred Vision (2137); Loss of consciousness (2418)
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Event Date 11/27/2023 |
Event Type
Injury
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Event Description
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An adhesive issue was reported with the adc sensor.The sensor prematurely detached, and the customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, headache, loss of speech, blurred vision and was unable to self-treat.The customer had contact with a healthcare professional (hcp) who administered unspecified intravenous medication 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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The reported product is not expected to be returned as reporter indicated the device was discarded.Physical investigation of product is not anticipated.Extended investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of all required investigation activities.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.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 adc sensor.The sensor prematurely detached, and the customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, headache, loss of speech, blurred vision and was unable to self-treat.The customer had contact with a healthcare professional (hcp) who administered unspecified intravenous medication 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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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.At this time product has not yet been returned for this complaint and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and libre sensors, no trends were identified that would indicate any product related issues.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.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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