Model Number 71940-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problems
Abscess (1690); Erythema (1840); Unspecified Infection (1930); Pain (1994)
|
Event Date 08/30/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Since no product has been returned, 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 the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates 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.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.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 reported experiencing an infection while wearing the adc freestyle libre sensor, reporting symptoms described as pain, abscess, "hard when touching", hot, and redness.Customer contacted a healthcare provider by phone and was advised to wash the insertion site with antiseptic and was also prescribed amoxicillin oral antibiotic, and clavulanic acid for treatment.There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|
|