Model Number 71953-01 |
Device Problems
Image Display Error/Artifact (1304); Unable to Obtain Readings (1516)
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Patient Problem
Hyperglycemia (1905)
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Event Date 05/31/2022 |
Event Type
Injury
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Event Description
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A complaint was received regarding a display message "errc-2" while using the adc device.As a result, on (b)(6) 2022, the customer had contact with a healthcare professional who provided half glimepiride, unspecified pills, and half an injection of insulin (type unknown) for a diagnosis of hyperglycemia.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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At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history review) 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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Manufacturer Narrative
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Reader (b)(6) has been returned and investigated with retained test strips.Visual inspection has been performed on the reader and no issues were observed.Built-in reader testing was performed and reader passed the test.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A complaint was received regarding a display message "errc-2" while using the adc device.As a result, on 31 may 2022, the customer had contact with a healthcare professional who provided half glimepiride, unspecified pills, and half an injection of insulin (type unknown) for a diagnosis of hyperglycemia.No further information 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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