Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Itching Sensation (1943); Pain (1994); Skin Infection (4544); Skin Inflammation/ Irritation (4545)
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Event Date 06/28/2021 |
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.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and 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 experiencing a skin reaction while wearing the adc freestyle libre 2 sensor.The customer experienced symptoms described as "growth underneath", abscess, itching, redness, pain, infection, and subcutaneous inflammation.The customer had removed the sensor and received unspecified antibiotic on (b)(6) 2021 as treatment.On (b)(6) 2021, the customer was seen at an emergency where the abscess was cut out open, drained, rinsed with saline and received clindamycin 150 mg as treatment.It was further reported there was no indication of a wider infection.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor 3mh0058a8ph has been returned and investigated.No physical damage was observed on the sensor patch.Observed no issues with returned adhesive.The sharp was not returned.No malfunction or product deficiency has been 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 experiencing a skin reaction while wearing the adc freestyle libre 2 sensor.The customer experienced symptoms described as "growth underneath", abscess, itching, redness, pain, infection, and subcutaneous inflammation.The customer had removed the sensor and received unspecified antibiotic on 27-jun-2021 as treatment.On 28-jun-2021, the customer was seen at an emergency where the abscess was cut out open, drained, rinsed with saline and received clindamycin 150 mg as treatment.It was further reported there was no indication of a wider infection.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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