Model Number 71953-01 |
Device Problems
Unable to Obtain Readings (1516); Power Problem (3010)
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Patient Problems
Headache (1880); Hyperglycemia (1905); Dizziness (2194); Diaphoresis (2452)
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Event Date 07/04/2023 |
Event Type
Injury
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Event Description
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A battery / no power issue was reported with the adc device.Customer was unable to obtain readings due to the device reader not working and they were not able to locate their back up.As a result, the customer experienced headache, sweating and dizziness.The customer was unable to self-treat, requiring treatment with lantus (long acting insulin) via injection (dose unknown) and ozempic (unknown dose) provided by a healthcare professional.No further treatment was reported.There was no report of death or permanent impairment 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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Event Description
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A battery/no power issue was reported with the adc device.Customer was unable to obtain readings due to the device reader not working and they were not able to locate their back up.As a result, the customer experienced headache, sweating and dizziness.The customer was unable to self-treat, requiring treatment with lantus (long acting insulin) via injection (dose unknown) and ozempic (unknown dose) provided by a healthcare professional.No further treatment was reported.There was no report of death or permanent impairment 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.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 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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