Model Number 71992-01 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problems
Hemorrhage/Bleeding (1888); Pain (1994)
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Event Date 08/24/2023 |
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 it has been determined that there was no indication that the product did not meet specification.The device history records (dhrs) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An insertion issue was reported with use of the abbott diabetes care (adc) device as the inserter needle was left in skin.As a result, customer experienced "intense bleeding", "pain", and was unable to self-treat, requiring contact with a healthcare professional (hcp).The hcp removed sensor and provided third-party treatment of "curettage the wound, interrupted the anticoagulant, and administered a pill for the pain." there was no report of death or permanent impairment associated with this event.
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Event Description
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An insertion issue was reported with use of the abbott diabetes care (adc) device as the inserter needle was left in skin.As a result, customer experienced "intense bleeding", "pain", and was unable to self-treat, requiring contact with a healthcare professional (hcp).The hcp removed sensor and provided third-party treatment of "curettage the wound, interrupted the anticoagulant, and administered a pill for the pain." there was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Applicator (b)(6) has been returned and investigated.Visual inspection has been performed on the applicator and no issues were observed.It is observed that the applicator was fired correctly, however loose bent sharp was observed sensor pack (b)(6) has been returned and investigated.Visual inspection was performed on the sensor pack and damaged transition features were observed.Lid was not completely peeled off.(b)(6) has been returned and investigated.Visually inspection has been performed on the sensor and no issues were observed.Sensor plug was not properly seated.Inspected the plug assembly and deformed snaps were observed.An extended investigation has been further performed.Visual inspection has been performed on the returned product and observed bent sharp, sensor pack lid was not completely peeled off and damaged to the transition features.Deformed snaps were observed causing improper seating of the sensor plug.Therefore, this issue is not confirmed to use due to incorrect assembly method.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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