Model Number 71562-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Cellulitis (1768); Erythema (1840); Pain (1994); Swelling (2091)
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Event Date 04/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.The date of manufacture is unknown.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A healthcare provider reported a patient/customer experienced an infection while wearing an adc freestyle libre sensor.The sensor had been inserted on (b)(6) 2019, but on (b)(6) 2019 the patient went to a hospital due to experiencing pain at the insertion site.The nurse instructed the patient to remove the sensor but he declined to do so; choosing to watch the site.Three days later ((b)(6) 2019), the patient returned to the hospital and the sensor was removed.Upon removal, the site was found to be ¿a little red, hot to touch, swollen arm, tension around the neck and shoulder¿.Additionally, there was a ¿white liquid¿ on the sensor tip.The patient was diagnosed with cellulitis and prescribed cefzon (cefdinir, an antibiotic).There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Performed a visual inspection on the returned libre pro sensor patch.No issues were observed.The sensor applicator and container were not returned.Extended investigation has also been performed for the reported complaint and determined that there was no indication that the product did not meet specification.Dhr (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrated 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.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.
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Event Description
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A healthcare provider reported a patient/customer experienced an infection while wearing an adc freestyle libre sensor.The sensor had been inserted on (b)(6) 2019, but on (b)(6) 2019 the patient went to a hospital due to experiencing pain at the insertion site.The nurse instructed the patient to remove the sensor but he declined to do so; choosing to watch the site.Three days later ((b)(6) 2019), the patient returned to the hospital and the sensor was removed.Upon removal, the site was found to be ¿a little red, hot to touch, swollen arm, tension around the neck and shoulder¿.Additionally, there was a ¿white liquid¿ on the sensor tip.The patient was diagnosed with cellulitis and prescribed cefzon (cefdinir, an antibiotic).There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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