Model Number 72081-01 |
Device Problem
High Readings (2459)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 12/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested for investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.N/a was selected for g4 as it is unknown if the user was using android, ios, or a reader with a fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A high reading issue was reported with the adc device.A customer experienced a seizure and loss of consciousness.The customer was treated with a glucose injection by a healthcare professional.A laboratory result of 81 mg/dl was also reported.There was no report of death or permanent injury 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.No product has been returned 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 libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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.Upon extended investigation, it was determined that the serial number provided by the customer (0c28l0erd) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.
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Event Description
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A high reading issue was reported with the adc device.A customer experienced a seizure and loss of consciousness.The customer was treated with a glucose injection by a healthcare professional.A laboratory result of 81 mg/dl was also reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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