Model Number 70914-70 |
Device Problem
Computer Software Problem (1112)
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Patient Problem
Loss of consciousness (2418)
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Event Date 09/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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The customer¿s product has been requested for investigation.A follow-up report will be filed 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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer initially reported that they were unable to retain settings on the adc device and was issued a replacement meter.The customer further indicated that due to a delivery delay of the replacement, they did not have a meter and experienced a loss of consciousness.No additional information was provided.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer initially reported that they were unable to retain settings on the adc device and was issued a replacement meter.The customer further indicated that due to a delivery delay of the replacement, they did not have a meter and experienced a loss of consciousness.No additional information was provided.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 and a valid serial number has not been provided.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 freestyle freedom lite meter, 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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