Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bruise/Contusion (1754)
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Event Date 10/01/2020 |
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 exact date that the incident occurred is unknown.The date entered in section is based on the customer report of "(b)(6) 2020".The device mfg date is unknown.The date entered 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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A customer reported experiencing bruising at the insertion site of the adc freestyle libre 2 sensor.The customer had contact with a dermatologist and was prescribed beparine as 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.Dose audit reports were reviewed and demonstrated 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.Clinical data was reviewed and no indication was found of any product clinical performance issues that would be expected to result or contribute to customer complaints.A tripped trend review was completed for the reported complaint and libre sensor, and there were no adverse trends that indicate any product related issues.If product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported experiencing bruising at the insertion site of the adc freestyle libre 2 sensor.The customer had contact with a dermatologist and was prescribed beparine as 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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