Model Number 71940-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hyperglycemia (1905); Nausea (1970); Polydipsia (2604)
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Event Date 10/21/2023 |
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 "scan again in 10" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced "thirst, weakness and nausea" and was unable to self-treat, requiring third-party administration of insulin(dose/type) for treatment.There was no report of death or permanent impairment associated with this event.
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Event Description
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A "scan again in 10" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced "thirst, weakness and nausea" and was unable to self-treat, requiring third-party administration of insulin(dose/type) for treatment.There was no report of death or permanent impairment 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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Search Alerts/Recalls
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