Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Post Traumatic Wound Infection (2447)
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Event Date 03/21/2023 |
Event Type
Injury
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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.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle 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.The date of event is unknown.The date entered in section b3 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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Customer experienced an adverse skin reaction with wear of the adc device.Customer experienced bleeding and wound infection after sensor removal and was unable to self-treat, requiring treatment with unspecified injection and flucloxacillin (antibiotics) provided by a healthcare professional (hcp).No further details were provided.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) 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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Event Description
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Customer experienced an adverse skin reaction with wear of the adc device.Customer experienced bleeding and wound infection after sensor removal and was unable to self-treat, requiring treatment with unspecified injection and flucloxacillin (antibiotics) provided by a healthcare professional (hcp).No further details were provided.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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