Model Number 71938-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Headache (1880); Hypoglycemia (1912); Nausea (1970); Loss of consciousness (2418); Polydipsia (2604)
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Event Date 05/21/2022 |
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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A ¿scan timeout/scan error¿ issue was reported with the adc device.A customer reported a scan error message during scanning and as a result, the customer had experienced headache, nausea, thirst, frequent urination, and a loss of consciousness.The customer was unable to self-treat, requiring treatment of dextrose tablets by the husband.No further information was provided.There was no report of death or permanent injury associated with this event.
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Event Description
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A ¿scan timeout/scan error¿ issue was reported with the adc device.A customer reported a scan error message during scanning and as a result, the customer had experienced headache, nausea, thirst, frequent urination, and a loss of consciousness.The customer was unable to self-treat, requiring treatment of dextrose tablets by the husband.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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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 reader was reviewed and the dhrs showed the libre reader 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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