Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Skin Discoloration (2074); Diaphoresis (2452)
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Event Date 10/29/2023 |
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 "try again in 10 minutes" sensor error message with the adc device and was therefore unable to obtain readings.As a result, the customer experienced "sweating and body discoloration." the customer was given sugar water and fruit juice by a third-party for treatment.There was no report of death or permanent injury associated with this event.
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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 customer reported a "try again in 10 minutes" sensor error message with the adc device and was therefore unable to obtain readings.As a result, the customer experienced "sweating and body discoloration." the customer was given sugar water and fruit juice by a third-party for treatment.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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