Model Number 71702-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problems
Abscess (1690); Unspecified Infection (1930); Itching Sensation (1943); Tingling (2171)
|
Event Date 01/21/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
The reported product is not expected to be returned as the sensor is discarded.A follow-up report will be filed if product is returned or additional information is obtained.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date 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.
|
|
Event Description
|
Customer's wife, calling on behalf of her husband who experienced an infection with symptoms of itching, tingling and abscess after 3 days of wearing an adc freestyle libre sensor.Customer had contact with a healthcare provider who prescribed an unspecified antibiotic for treatment.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification dhrs (device history review) for all libre sensors and libre sensor kits within expiration at the time of complaint were reviewed and the dhr review showed no there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and libre sensors and showed no trips.If the product is returned, the case will be re-opened and a physical investigation will be performed.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.
|
|
Event Description
|
Customer's wife, calling on behalf of her husband who experienced an infection with symptoms of itching, tingling and abscess after 3 days of wearing an adc freestyle libre sensor.Customer had contact with a healthcare provider who prescribed an unspecified antibiotic for treatment.There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|