Model Number 72081-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bruise/Contusion (1754); Pain (1994); Skin Infection (4544); Skin Inflammation/ Irritation (4545)
|
Event Date 03/30/2023 |
Event Type
Injury
|
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 manufacturing date 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.
|
|
Event Description
|
A customer reported experiencing a skin reaction while wearing the adc device.The customer experienced symptoms described as "spot of the sensor turned blue, bruising, inflammation, and pain" at the sensor insertion site.The customer had contact with a healthcare professional who removed the sensor and prescribed antibiotics for treatment.It was further reported that the customer took unspecified pills and insulin (type/dose unknown).There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
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.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor products.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 freestyle libre sensor continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential 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 unk.
|
|
Event Description
|
A customer reported experiencing a skin reaction while wearing the adc device.The customer experienced symptoms described as "spot of the sensor turned blue, bruising, inflammation, and pain" at the sensor insertion site.The customer had contact with a healthcare professional who removed the sensor and prescribed antibiotics for treatment.It was further reported that the customer took unspecified pills and insulin (type/dose unknown).There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|