Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Purulent Discharge (1812); Skin Infection (4544); Swelling/ Edema (4577)
|
Event Date 09/19/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.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.Dhrs (device history record) 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 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.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
|
An adverse skin reaction was reported while wearing the adc device.The customer experienced symptoms described as "thick arm, pully very hot and pus" at the sensor site and also reported "suffering from a fever, sensor area on the arm was much warmer than rest of body." the customer further reported having contact with a healthcare professional (general practitioner) who provided unspecified antibiotics as treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
Sensor (b)(6) was returned and investigated.Visual inspection was performed, and no issues were observed.Visual inspection was performed on the returned adhesive and no issues were observed.No malfunction or product deficiency was identified.This issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
|
|
Event Description
|
An adverse skin reaction was reported while wearing the adc device.The customer experienced symptoms described as "thick arm, pully very hot and pus" at the sensor site and also reported "suffering from a fever, sensor area on the arm was much warmer than rest of body." the customer further reported having contact with a healthcare professional (general practitioner) who provided unspecified antibiotics as treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|