Model Number 71953-01 |
Device Problems
Failure to Power Up (1476); Unable to Obtain Readings (1516); Shipping Damage or Problem (1570)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 04/10/2023 |
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.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A delivery delay with a replacement abbott diabetes care (adc) device was reported.The replacement device was issued due to unable to test due to the reader not powering on with button press or test strip insertion.Due to delivery delay, customer experienced a loss of consciousness and was unable to self-treat, requiring third-party treatment of "food" orally by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
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Event Description
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A delivery delay with a replacement abbott diabetes care (adc) device was reported.The replacement device was issued due to unable to test due to the reader not powering on with button press or test strip insertion.Due to delivery delay, customer experienced a loss of consciousness and was unable to self-treat, requiring third-party treatment of "food" orally 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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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.Extended investigation has been performed for the reported complaint and 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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Search Alerts/Recalls
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