Model Number 71992-01 |
Device Problem
Product Quality Problem (1506)
|
Patient Problem
Electric Shock (2554)
|
Event Date 02/18/2023 |
Event Type
malfunction
|
Event Description
|
Customer reports an "electric-like shock" from their adc device.There was no report of death, serious injury, or mistreatment associated with this event.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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 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, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
Customer reports an "electric-like shock" from their adc device.There was no report of death, serious injury, or mistreatment associated with this event.
|
|
Search Alerts/Recalls
|