Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Skin Infection (4544)
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Event Date 12/21/2023 |
Event Type
Injury
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Event Description
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A customer reported experiencing a skin reaction while wearing the adc device, with symptoms described as "inflated", pain, and infection at the sensor insertion site.The customer called the healthcare professional and then self-presented at a hospital where they received unspecified treatment.The customer further reported that a surgery was performed to remove the infection however, no further details were provided.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.A follow-up report will be submitted once additional information is obtained.The device manufacturing 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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A customer reported experiencing a skin reaction while wearing the adc device, with symptoms described as "inflated", pain, and infection at the sensor insertion site.The customer called the healthcare professional and then self-presented at a hospital where they received unspecified treatment.The customer further reported that a surgery was performed to remove the infection however, no further details were provided.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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An extended investigation has been performed for the reported complaint and it has been determined that 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.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.Sensor (b)(6) was returned and investigated.Visual inspection was performed, and no issues were observed.Visual inspection was performed on the returned adhesive and no issues were observed.No malfunction or product deficiency was identified.This issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.".
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Search Alerts/Recalls
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