Model Number 71940-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Rash (2033); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
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Event Date 05/14/2022 |
Event Type
Injury
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Manufacturer Narrative
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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 kit were reviewed, and the dhrs 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 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, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A caller reported customer experienced a skin reaction while wearing an adc device and experienced symptoms described as skin rash, burning, and itching.The caller reported paramedics cleansed insertion site and unknown cream was provided for treatment.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigation.No physical damage was observed on the sensor patch.Adhesive was not returned.If the adhesive 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.
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Event Description
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A caller reported customer experienced a skin reaction while wearing an adc device and experienced symptoms described as skin rash, burning, and itching.The caller reported paramedics cleansed insertion site and unknown cream was provided for treatment.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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