Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Erythema (1840); Pain (1994); Discomfort (2330); Skin Infection (4544)
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Event Date 09/15/2022 |
Event Type
Injury
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Event Description
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An adverse skin reaction was reported with wear of the abbott diabetes care (adc) device.As a result, customer experienced "discomfort/pain", "purulent abscesses", "redness", "infection at the sensor site" and had contact with a healthcare professional (hcp) who prescribed clamoxyl antibiotics, twice daily for seven days, 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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The product has been requested back for an investigation.At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and 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 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.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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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Search Alerts/Recalls
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