Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
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Event Date 05/10/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested for investigation.A follow-up report will be submitted once additional information is obtained.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.
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Event Description
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An adverse skin reaction was reported with wear of the adc device.Customer experienced symptoms described as pain, bruising, swelling, tenderness, and redness at the sensor site and had contact with an hcp who prescribed antibiotic cream and tablets for treatment.There was no report of death or permanent impairment associated with this event.
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Event Description
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An adverse skin reaction was reported with wear of the adc device.Customer experienced symptoms described as pain, bruising, swelling, tenderness, and redness at the sensor site and had contact with an hcp who prescribed antibiotic cream and tablets for treatment.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.Sensor plug was properly seated.Visual inspection has been performed on the sensor plug, no failure modes were observed.No further investigation can be performed due to no product returned.Adhesive was not 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 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 additional product is returned, an investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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