Model Number 71953-01 |
Device Problem
Failure to Power Up (1476)
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Patient Problems
Pain (1994); Vomiting (2144); Diabetic Ketoacidosis (2364)
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Event Date 10/23/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.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 device history review (dhrs) 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 battery/no power issue was reported with the abbott diabetes care (adc) device reader.Customer was unable to test due to the reader not powering on with button press or test strip insertion.As a result, customer experienced "vomiting", "gastric pain", and was unable to self-treat, requiring contact with emergency services (es) who transported customer to the hospital.At the hospital, a healthcare professional (hcp) provided intravenous insulin (type/dose unspecified) for a diagnosis of diabetic ketoacidosis (dka).There was no report of death or permanent impairment associated with this event.
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Event Description
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A battery/no power issue was reported with the abbott diabetes care (adc) device reader.Customer was unable to test due to the reader not powering on with button press or test strip insertion.As a result, customer experienced "vomiting", "gastric pain", and was unable to self-treat, requiring contact with emergency services (es) who transported customer to the hospital.At the hospital, a healthcare professional (hcp) provided intravenous insulin (type/dose unspecified) for a diagnosis of diabetic ketoacidosis (dka).There was no report of death or permanent impairment 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 returned reader and no issues were observed.Reader turns on with button depression.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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