Model Number 71953-01 |
Device Problem
Break (1069)
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Patient Problems
Hypoglycemia (1912); Shaking/Tremors (2515)
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Event Date 06/20/2023 |
Event Type
Injury
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Event Description
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A device damage issue was reported with use of the abbott diabetes care (adc) reader.Customer reported reader was "damaged from drink spilling on it" and they were unable to obtain readings or monitor glucose levels.As a result, customer experienced "shaking", "pale", "hunger", and was unable to self-treat; requiring third-party treatment of "25cl of apple juice" by a non-healthcare professional.There was no report of death or permanent injury 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.All pertinent information available to abbott diabetes care has been submitted.
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Manufacturer Narrative
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Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and cracked screen was observed.The readers log was downloaded and observed readings in the reader indicating that this issue is not an out of box failure.Therefore, issue is not confirmed to use due to cracked screen.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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A device damage issue was reported with use of the abbott diabetes care (adc) reader.Customer reported reader was "damaged from drink spilling on it" and they were unable to obtain readings or monitor glucose levels.As a result, customer experienced "shaking", "pale", "hunger", and was unable to self-treat; requiring third-party treatment of "25cl of apple juice" by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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