Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hemorrhage/Bleeding (1888); Pain (1994); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 10/01/2023 |
Event Type
Injury
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Event Description
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A delivery delay with a replacement adc device was reported.The replacement device was issued due to a "replace sensor" error message displaying on the same day of the sensor application.Due to a delivery issue, the customer was unable to monitor their glucose and experienced a loss of consciousness and a seizure.The customer further reported experiencing symptoms of pain, bleeding, and urine infection for which the customer was treated with antibiotics by a healthcare professional (hcp).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 device manufacturing 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.
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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.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.The dhrs (device history review) 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.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 delivery delay with a replacement adc device was reported.The replacement device was issued due to a "replace sensor" error message displaying on the same day of the sensor application.Due to a delivery issue, the customer was unable to monitor their glucose and experienced a loss of consciousness and a seizure.The customer further reported experiencing symptoms of pain, bleeding, and urine infection for which the customer was treated with antibiotics by a healthcare professional (hcp).There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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