Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
|
Event Date 06/13/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg 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 experienced a skin reaction at the sensor site while wearing an abbott diabetes care (adc) device.As a result, customer experienced an "allergic reaction", "itching", "redness", "inflammation" and had contact with a healthcare professional (hcp) who prescribed "cortisone ointment spray" (dose unspecified) for treatment.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.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.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.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.The dhrs (device history review) for libre sensor kits were reviewed and the dhrs showed the libre sensor kits passed all tests prior to release.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.
|
|
Event Description
|
A customer experienced a skin reaction at the sensor site while wearing an abbott diabetes care (adc) device.As a result, customer experienced an "allergic reaction", "itching", "redness", "inflammation" and had contact with a healthcare professional (hcp) who prescribed "cortisone ointment spray" (dose unspecified) for treatment.There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|