Model Number 71953-01 |
Device Problems
Unable to Obtain Readings (1516); Charging Problem (2892)
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Patient Problems
Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 03/15/2023 |
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 not charging.As a result, the customer experienced a loss of consciousness and/or seizure.No treatment information was provided.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.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered 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/no power issue was reported with the adc device.Customer was unable to obtain readings due to the device not charging.As a result, the customer experienced a loss of consciousness and/or seizure.No treatment information was provided.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 and a valid lot or serial number was not provided; therefore it is not possible to check dhr for cable and adapter.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and libre reader, no trends were identified that would indicate any product related issues.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.Upon extended investigation, it was determined that the serial number provided by the customer ((b)(6)) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.
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Search Alerts/Recalls
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