Model Number 71609-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Irritation (1941); Itching Sensation (1943); Rash (2033); Swelling (2091); Reaction (2414)
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Event Date 11/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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The customer¿s products have been requested for an investigation.A follow-up report will be filed once additional information is obtained.The actual date of the event is unknown.The date listed is the date abbott diabetes care became aware of the event.The case was reported via a complaint form by a physician in (b)(6).All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A physician reported via a complaint form that a patient at a diabetes center in (b)(6) experienced intense itching and irritation after application of the freestle libre pro sensor.The sensor was removed on the day following its application, and the area was found to be ¿reddish, itchy and slightly indurated¿.The physician noted that ¿even after 25 days, she continues to develop itching and rashes all over the body.The original site is blackish with intensive itching sensation.¿ the physician treated the patient with an unspecified ¿mild steroid cream¿, and fexofenadine (an antihistamine), with no response.No further diagnoses or treatment were reported.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: (serial number) has been updated based on the returned product.Sensor (b)(4) was returned and investigated.Visual inspection was performed and no issues were observed.Investigation of returned product did not identify product deficiencies.Extended investigation of this issue reviewed libre sensor adhesive materials, libre clinical trial data, and review of manufacturing records.The investigation did not find any product or process deficiencies that would contribute to the skin irritation issue.Current labeling advises customer to discontinue use of sensor if irritation occurs.Current product surveillance data indicates that the product is performing as expected.Investigation results determined there was no malfunction, deficiency or deterioration in the characteristics and /or performance or any inadequacy in the labeling or instructions for use of the device identified.This also serves as a correction report.The correction was found on (b)(6) 2017.The reported ¿b4 - report date¿ was incorrect on the initial submission.The correct report date is (b)(6), 2016.
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Event Description
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A physician reported via a complaint form that a patient at a diabetes center in (b)(6) experienced intense itching and irritation after application of the freestle libre pro sensor.The sensor was removed on the day following its application, and the area was found to be ¿reddish, itchy and slightly indurated¿.The physician noted that ¿even after 25 days, she continues to develop itching and rashes all over the body.The original site is blackish with intensive itching sensation.¿ the physician treated the patient with an unspecified ¿mild steroid cream¿, and fexofenadine (an antihistamine), with no response.No further diagnoses or treatment were reported.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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A device history record (dhr) review of the sensor was completed.The dhr for sensor serial number (b)(4) indicated the device was performing within its performance claims and met the manufacturer's quality specifications prior to its release.This also serves as a correction report.
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Event Description
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A physician reported via a complaint form ta physician reported via a complaint form that a patient at a diabetes center in india experienced intense itching and irritation after application of the freestyle libre pro sensor.The sensor was removed on the day following its application, and the area was found to be ¿reddish, itchy and slightly indurated¿.The physician noted that ¿even after 25 days, she continues to develop itching and rashes all over the body.The original site is blackish with intensive itching sensation.¿ the physician treated the patient with an unspecified ¿mild steroid cream¿, and fexofenadine (an antihistamine), with no response.No further diagnoses or treatment were reported.There was no report of death or permanent injury associated with this event that a patient at a diabetes center in (b)(6) experienced intense itching and irritation after application of the freestyle libre pro sensor.The sensor was removed on the day following its application, and the area was found to be ¿reddish, itchy and slightly indurated¿.The physician noted that ¿even after 25 days, she continues to develop itching and rashes all over the body.The original site is blackish with intensive itching sensation.¿ the physician treated the patient with an unspecified ¿mild steroid cream¿, and fexofenadine (an antihistamine), with no response.No further diagnoses or treatment were reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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