Model Number 71992-01 |
Device Problem
Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 04/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.Dhrs (device history record) for the freestyle libre sensor kit were reviewed and the dhrs showed the 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 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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A caller reported that the sensor tip of the adc freestyle libre 2 sensor remained in the skin of the customer.The customer had contact with a healthcare professional who surgically removed the sensor tip and no further treatment was required.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no issues were observed.Did not observe severed sensor tail.No malfunction or product deficiency was identified.Therefore, the 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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A caller reported that the sensor tip of the adc freestyle libre 2 sensor remained in the skin of the customer.The customer had contact with a healthcare professional who surgically removed the sensor tip and no further treatment was required.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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