Model Number 71992-01 |
Device Problems
Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Hemorrhage/Bleeding (1888)
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Event Date 04/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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The reported product is not expected to be returned as reporter indicated the device was discarded.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.Physical investigation of product is not anticipated as reporter indicated device was discarded.Extended investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of all required investigation activities.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A caregiver reported the customer¿s adc freestyle libre 2 sensor detached during insertion and experienced symptoms described as ¿skin up¿, bruising, and bleeding.The customer had contact with the emergency doctor and received unspecified treatment.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 and a valid serial number has not been provided.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 demonstrated 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.Clinical data was reviewed and confirmed that freestyle libre sensor continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential product related issues.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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A caregiver reported the customer¿s adc freestyle libre 2 sensor detached during insertion and experienced symptoms described as ¿skin up¿, bruising, and bleeding.The customer had contact with the emergency doctor and received unspecified treatment.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that the 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 libre sensor, 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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A caregiver reported the customer¿s adc freestyle libre 2 sensor detached during insertion and experienced symptoms described as ¿skin up¿, bruising, and bleeding.The customer had contact with the emergency doctor and received unspecified treatment.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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