Model Number 71992-01 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
Electric Shock (2554)
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Event Date 06/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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No product has been returned, extended investigation is pending at this time.A follow- up report will be submitted once additional information is obtained.The device manufacturer date for the reported sensor is unknown.The date entered 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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Customer reports an electric shock from their adc device.There was no report of death, serious injury, or mistreatment associated with this event.
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Event Description
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Customer reports an electric shock from their adc device.There was no report of death, serious injury, or mistreatment 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.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 ((b)(6)) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unknown.
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Search Alerts/Recalls
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