Model Number 71702-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)
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Event Date 11/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.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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Customer reported experiencing an allergic skin reaction while wearing an adc freestyle libre sensor for 3 days.Customer further reported experiencing symptoms described as burning, itching, and eczema, and having contact with a healthcare professional on (b)(6) 2018 who prescribed locoid (hydrocortisone) cream for treatment.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Additional information: (device mfg date) has been updated based on the returned product download.Sensor (b)(4) has been returned and investigated.Visual inspection has been performed and no issues were observed.The adhesive was returned with the sensor puck.Extended investigation has also been performed.Dose audit reports and environmental monitoring reports, including bioburden and endotoxin testing, were reviewed for the quarterly period during which each complaint unit was manufactured.No abnormalities were found, and the investigation showed all processes were effective.No malfunction or product deficiency was identified.
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Event Description
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Customer reported experiencing an allergic skin reaction while wearing an adc freestyle libre sensor for 3 days.Customer further reported experiencing symptoms described as burning, itching, and eczema, and having contact with a healthcare professional on (b)(6) 2018 who prescribed locoid (hydrocortisone) cream for 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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