Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Fall (1848); Hypoglycemia (1912); Dizziness (2194); Loss of consciousness (2418)
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Event Date 02/01/2022 |
Event Type
Injury
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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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Event Description
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An alarm issue was reported with the adc freestyle libre 2 sensor.Customer reported the low glucose alarm did not sound and experienced dizziness, fall and a loss of consciousness.Customer was able to recover by themselves and self-treat with juice and glucose gel.Customer was seen at the hospital due to head injuries and trauma after the fall and was provided nolotil via iv and placed staples at the site of injury.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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Event Description
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An alarm issue was reported with the adc freestyle libre 2 sensor.Customer reported the low glucose alarm did not sound and experienced dizziness, fall and a loss of consciousness.Customer was able to recover by themselves and self-treat with juice and glucose gel.Customer was seen at the hospital due to head injuries and trauma after the fall and was provided nolotil via iv and placed staples at the site of injury.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Additional information: d4 (expiration date) and h4 (device mfg date) were updated based on an extended investigation.Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specifications.Dhrs (device history review) for the libre sensor and libre sensor kit were reviewed, and the dhr showed the libre sensor and sensor kits passed all tests prior to release.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An alarm issue was reported with the adc freestyle libre 2 sensor.The customer reported the low glucose alarm did not sound and experienced dizziness, fall, and a loss of consciousness.The customer was able to recover by themselves and self-treat with juice and glucose gel.The customer was seen at the hospital due to head injuries and trauma after the fall and was provided nolotil via iv and placed staples at the site of injury.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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