Model Number 71953-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Blurred Vision (2137); Chills (2191); Loss of consciousness (2418); Diaphoresis (2452); Shaking/Tremors (2515)
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Event Date 05/09/2022 |
Event Type
Injury
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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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre reader were 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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Event Description
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A customer reported an "error-9" with the adc device.The customer was therefore unable to obtain glucose results and experienced sweating, chills, tremors, blurred vision, and loss of consciousness.No further information regarding event 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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Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the reader and damaged usb port was observed.Due to the damaged usb port the reader was not able to be charged and so the reader did not power on.The reader was further de-cased and placed into the reader test fixture to download log.Therefore, issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported an "error-9" with the adc device.The customer was therefore unable to obtain glucose results and experienced sweating, chills, tremors, blurred vision, and loss of consciousness.No further information regarding event was 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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