Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Discomfort (2330); Convulsion/Seizure (4406)
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Event Date 10/10/2023 |
Event Type
Injury
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Event Description
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A scan again in 10 minutes error message was reported with the abbott device care (adc) device and customer was unable to obtain readings.As a result, customer experienced "feeling unwell and convulsing".No treatment was reported, and no further information was provided.There was no report of death or permanent injury 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 mfg 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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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.The available tripped trend reports were reviewed for libre sensor and perception code for the last year.The review identified a tripped trend for this perception code.This tripped trend was addressed in the tracking, trending review meeting, and investigated.The investigation concluded that the tripped trend was not correlated with a product nonconformance.Trends are regularly monitored and investigated when exceeding established thresholds to evaluate for causes associated with the product.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 scan again in 10 minutes error message was reported with the abbott device care (adc) device and customer was unable to obtain readings.As a result, customer experienced "feeling unwell and convulsing".No treatment was reported, and no further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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