Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
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Event Date 05/07/2021 |
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 skin reaction was reported with the freestyle libre 2 sensor.A customer noted experiencing symptoms of bruising and itching at the sensor site and had contact with a healthcare provider who prescribed cortisone ointment 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 investigated.No physical damage was observed on the sensor patch.Observed adhesive was not returned.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A skin reaction was reported with the freestyle libre 2 sensor.A customer noted experiencing symptoms of bruising and itching at the sensor site and had contact with a healthcare provider who prescribed cortisone ointment 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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