Model Number 71953-01 |
Device Problem
Power Problem (3010)
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Patient Problems
Hyperglycemia (1905); Loss of consciousness (2418)
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Event Date 06/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested for 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 battery/no power issue was reported with the adc device.Customer was unable to obtain readings due to the device "sometimes turns on" and "not starting up".As a result, the customer experienced dizziness and suffered a loss of consciousness and was unable to self-treat, requiring unspecified treatment by third-party.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 serial number has not been provided for reader.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.A tripped trend review was conducted for the reported complaint and fs 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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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 "sometimes turns on" and "not starting up".As a result, the customer experienced dizziness and suffered a loss of consciousness and was unable to self-treat, requiring unspecified treatment by third-party.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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