Model Number 71940-01 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
Hypoglycemia (1912)
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Event Date 12/05/2022 |
Event Type
Injury
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Event Description
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A bent inserter needle was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced hypoglycemia and was unable to self-treat.A reading of 48 mg/dl was obtained on the hospital meter and customer was treated with oral glucose by healthcare provider.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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The customer's product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing 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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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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.Clinical data was reviewed and confirmed that the freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and libre sensor, no trends were identified that would indicate any product related issues.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 bent inserter needle was reported with the adc device and customer was therefore unable to apply the device and monitor glucose levels.As a result, the customer experienced hypoglycemia and was unable to self-treat.A reading of 48 mg/dl was obtained on the hospital meter and customer was treated with oral glucose by healthcare provider.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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