Model Number 71992-01 |
Device Problems
No Device Output (1435); Failure to Fire (2610)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 10/19/2022 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested for 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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Event Description
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A customer that during insertion the adc device insertion, the sensor failed to apply to the skin.The customer was found unconscious by their nurse who obtained a glucose result of 525 mg/dl and treatment of insulin (type/dose unknown) was administered for treatment.There was no report of death or permanent injury associated with this event.
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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 customer that during insertion the adc device insertion, the sensor failed to apply to the skin.The customer was found unconscious by their nurse who obtained a glucose result of 525 mg/dl and treatment of insulin (type/dose unknown) was administered for treatment.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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