Model Number 71702-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)
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Event Date 11/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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The customer's products have been requested for investigation.A follow-up report will be filed once the meter is returned or additional information is obtained.The actual date when the event occurred is unknown.The date listed is an approximation based on the details provided by the customer indicating the event took place in the beginning of (b)(6).The date of manufacture is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Customer reported experiencing an allergic skin reaction while wearing an adc freestyle libre sensor.It was further reported that in the beginning of (b)(6) (date/time were not specified) the customer noticed the insertion site was ¿itching, had redness, bumps and burning, but no pain¿ and added that the sensor detached approximately three hours after insertion.Customer noted having contact with a healthcare provider and was prescribed soderm cream (betamethasone, a corticosteroid).No additional treatment was required.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Additional information: ( sensor serial number) has been updated.No product has been returned.Extended investigation has been performed for the reported complaint and it has been determined that 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 and environmental monitoring reports were reviewed for issues relating to sterility of the product.The sensor component has no impact on product sterility and therefore, sensor components dhrs were not reviewed.Sensor kit dhrs have been reviewed to assess the manufacturing process, which includes the application of the adhesive to the puck.A dhr (device history review) for the freestyle libre sensor kit was reviewed and the dhr showed the 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.The dose audit report covers the required time period.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.
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Event Description
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Customer reported experiencing an allergic skin reaction while wearing an adc freestyle libre sensor.It was further reported that in the beginning of november (date/time were not specified) the customer noticed the insertion site was ¿itching, had redness, bumps and burning, but no pain¿ and added that the sensor detached approximately three hours after insertion.Customer noted having contact with a healthcare provider and was prescribed soderm cream (betamethasone, a corticosteroid).No additional treatment was required.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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