Model Number 71953-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Muscle Weakness (1967)
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Event Date 09/13/2022 |
Event Type
Injury
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Event Description
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An alarm issue was reported with the adc device.The customer reported the low alarm did not sound and as a result, the customer experienced symptoms described as weakness and was unable to self-treat.Customer had contact with a third-party (caregiver) who administered sublingual sugar as treatment.No further information was provided.There was no report of death or permanent impairment 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 date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.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.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 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.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 alarm did not sound and as a result, the customer experienced symptoms described as weakness and was unable to self-treat.Customer had contact with a third-party (caregiver) who administered sublingual sugar as treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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