Model Number 71702-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Abscess (1690); Inflammation (1932); Infection, Pyrogenic (2246)
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Event Date 11/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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The customer's products have been requested for investigation.A follow-up report will be filed once the meter is returned or additional information is obtained.The date of manufacture is unknown.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Customer¿s wife reported customer experienced an abscess while wearing an adc freestyle libre sensor.It was further reported that after inserting the sensor the customer experienced a ¿sting in the right upper arm¿.Ten days later, the area became inflamed, so the customer self-presented to a healthcare provider on (b)(6) 2017.Customer was diagnosed with an abscess and was treated with an unspecified antibiotic, which was taken for 14 days.Customer also received daily wound care from a nurse.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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.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 kits.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 dose audit report covers the required time period.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.
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Event Description
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Customer¿s wife reported customer experienced an abscess while wearing an adc freestyle libre sensor.It was further reported that after inserting the sensor the customer experienced a ¿sting in the right upper arm¿.Ten days later the area became inflamed, so the customer self-presented to a healthcare provider on (b)(6) 2017.Customer was diagnosed with an abscess and was treated with an unspecified antibiotic, which was taken for 14 days.Customer also received daily wound care from a nurse.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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