Model Number 71702-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Abscess (1690); Erythema (1840); Unspecified Infection (1930); Pain (1994)
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Event Date 08/27/2018 |
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 date of event 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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Abbott diabetes care (adc) received a medwatch report which reported the following information: customer who is also a healthcare professional reported experiencing an allergic reaction while wearing an adc freestyle libre sensor.Customer experienced symptoms described as "erythema of skin, firm 2-3 mm nodule at the insertion point, abscess like features at skin surface, warm surrounding skin, 2 to 3 cms firm nodule in skin, painful to light touch, pain so significant that at night he elevated arm on another pillow so that the area should not touch the bed".Customer self treated with fluocinonide (tipital steroid) cream and neosporin (antibiotic) but the skin nodule still persisted after the treatment.Customer further reported that the skin was cleaned with soap, hibiclens (chlorhexidine - topical antiseptic), betadine (povidone-iodine - antiseptic) and alcohol pads before applying the sensor.There was no report of death or permanent injury associated with this event.
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Event Description
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Abbott diabetes care (adc) received a medwatch report which reported the following information: customer who is also a healthcare professional reported experiencing an allergic reaction while wearing an adc freestyle libre sensor.Customer experienced symptoms described as "erythema of skin, firm 2-3 mm nodule at the insertion point, abscess like features at skin surface, warm surrounding skin, 2 to 3 cms firm nodule in skin, painful to light touch, pain so significant that at night he elevated arm on another pillow so that the area should not touch the bed".Customer self treated with fluocinonide (topital steroid) cream and neosporin (antibiotic) but the skin nodule still persisted after the treatment.Customer further reported that the skin was cleaned with soap, hibiclens (chlorhexidine - topical antiseptic), betadine (povidone-iodine - antiseptic) and alcohol pads before applying the sensor.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.Dhrs (device history review) for all libre sensors and libre sensor kits within expiration at the time of complaint were reviewed and the dhr review showed no there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint.Dose audit reports were reviewed and demonstrates 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 libre sensors 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, there were no confirmed complaints within the trend data in this review.Therefore, there were no adverse trends that indicate any potential product related issues.If the product is returned, the case will be re-opened and a physical investigation will be performed.
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Search Alerts/Recalls
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