Model Number 71940-01 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
Hyperglycemia (1905)
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Event Date 01/06/2022 |
Event Type
Injury
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Event Description
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Customer noticed that the adc freestyle libre sensor's needle was bent and therefore could not obtain scan readings.Customer experienced symptoms of hyperglycemia and had contact with healthcare provider and received 2 insulin shots for the diagnosis of hyperglycemia.Customer also self-treated with glipizide and was advised to take 10 units of insulin in the morning and in the night.Based on the information provided, there was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg 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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Customer noticed that the adc freestyle libre sensor's needle was bent and therefore could not obtain scan readings.Customer experienced symptoms of hyperglycemia and had contact with healthcare provider and received 2 insulin shots for the diagnosis of hyperglycemia.Customer also self-treated with glipizide and was advised to take 10 units of insulin in the morning and in the night.Based on the information provided, there was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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