Model Number 71938-01 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problems
Fatigue (1849); Dizziness (2194); Loss of consciousness (2418); Diaphoresis (2452); Convulsion/Seizure (4406)
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Event Date 02/18/2023 |
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 manufacturing 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 battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery.As a result, customer experienced a loss of consciousness, seizure, fatigue, sweating, weakness, in stability, dizziness and had contact with an healthcare professional (hcp) and was treated unspecified oral treatment and unspecified nasal spray for diagnosis of hyperglycemia.No further treatment was required.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/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery.As a result, customer experienced a loss of consciousness, seizure, fatigue, sweating, weakness, in stability, dizziness and had contact with an healthcare professional (hcp) and was treated unspecified oral treatment and unspecified nasal spray for diagnosis of hyperglycemia.No further treatment was required.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 and kit pack for verification of correct cable and adapter was reviewed.The dhrs showed the libre reader passed all tests prior to release and correct cable and adapter was part of the kit pack.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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