Model Number 71992-01 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Headache (1880); Nausea (1970); Convulsion/Seizure (4406)
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Event Date 06/15/2023 |
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 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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Event Description
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A customer reported a delivery issue associated with a replacement adc device.The customer initially reported that the adc device had a bent needle and was issued a replacement.The customer reported that due to a delivery delay, they did not have a device to monitor glucose with and experienced symptoms of seizure, nausea, severe headache, and hypertension, however there was no report of treatment from a third party.No further details were 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.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 sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit 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.This serves as a correction report.
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Event Description
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A customer reported a delivery issue associated with a replacement adc device.The customer initially reported that the adc device had a bent needle and was issued a replacement.The customer reported that due to a delivery delay, they did not have a device to monitor glucose with and experienced symptoms of seizure, nausea, severe headache, and hypertension, however there was no report of treatment from a third party.No further details were 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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