Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Fatigue (1849); Hypoglycemia (1912); Muscle Weakness (1967); Blurred Vision (2137); Confusion/ Disorientation (2553)
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Event Date 10/24/2022 |
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 determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.The date the incident occurred is unknown.The date entered in is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in is the date abbott diabetes care became aware of the event.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 alarm issue was reported with the adc device.The customer reported the low and high alarm did not sound and as a result, the customer experienced symptoms described as "low blood sugar, blurred vision, weakness, disorientation and tiredness" and reported self-treating with candy.In addition, customer received unspecified treatment by a healthcare professional.No further information was reported.There was no report of death or permanent injury associated with this event.
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Event Description
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An alarm issue was reported with the adc device.The customer reported the low and high alarm did not sound and as a result, the customer experienced symptoms described as "low blood sugar, blurred vision, weakness, disorientation and tiredness" and reported self-treating with candy.In addition, customer received unspecified treatment by a healthcare professional.No further information was reported.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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At this time, product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.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.This serves as a correction report.Section h-10 was incorrectly documented in the previous initial report.Section h-10 has been updated.
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Search Alerts/Recalls
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