Model Number 71992-01 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 09/14/2022 |
Event Type
malfunction
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Event Description
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Customer reports an electric shock while wearing 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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The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturer date for the reported sensor 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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Customer reports an electric shock while wearing 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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Section d-4 (expiration date) and h-4 ( device mfg date) have been updated based on the extended investigation.Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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