Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Pain (1994); Skin Infection (4544)
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Event Date 05/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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The reported product is not expected to be returned as reporter indicated the device was discarded.All pertinent information available to abbott diabetes care has been submitted.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date 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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A caller reported the customer experiencing a skin reaction while wearing the adc freestyle libre sensor, with symptoms of bruising, pain, and insertion site infection with a large hematoma.The customer had contact with a healthcare provider and received unspecified treatment.The caller further reported the sensor had to be surgically removed.There was no report of death or permanent injury associated with this event.
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Event Description
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A caller reported the customer experiencing a skin reaction while wearing the adc freestyle libre sensor, with symptoms of bruising, pain, and insertion site infection with a large hematoma.The customer had contact with a healthcare provider and received unspecified treatment.The caller further reported the sensor had to be surgically removed.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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No product has been returned and 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 review) 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, 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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Search Alerts/Recalls
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