Model Number 71953-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Tachycardia (2095); Diaphoresis (2452)
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Event Date 10/24/2022 |
Event Type
Injury
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Event Description
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An alarming issue was reported with the adc device.A customer reported encountering a signal loss therefore, the sensor¿s alarm failed to function.As a result, the customer experienced sweating and a racing heart and was unable to self-treat, requiring treatment of glucagon injection and juice by a non-healthcare professional.No further information was provided.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 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 sensor and sensor kits, and 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.The date of event is unknown.The date entered in section is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section 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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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 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 libre reader, and 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.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report: h10 - additional mfg narrative has been corrected.
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Event Description
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An alarming issue was reported with the adc device.A customer reported encountering a signal loss therefore, the sensor¿s alarm failed to function.As a result, the customer experienced sweating and a racing heart and was unable to self-treat, requiring treatment of glucagon injection and juice by a non-healthcare professional.No further information was 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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