Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Hypoglycemia (1912); Numbness (2415); Diaphoresis (2452); Shaking/Tremors (2515)
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Event Date 04/21/2023 |
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 and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor kit passed all tests prior to release.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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An adhesive issue was reported with the adc sensor.The sensor prematurely detached and as a result, customer experienced symptoms of sweating, shaking, and numbness.The customer was treated with glucagon injection by their spouse.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.No physical damage was observed on the returned sensor patch and no issues were observed with the returned sensor adhesive.No malfunction or product deficiency has been identified.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An adhesive issue was reported with the adc sensor.The sensor prematurely detached and as a result, customer experienced symptoms of sweating, shaking, and numbness.The customer was treated with glucagon injection by their spouse.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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