Model Number 71953-01 |
Device Problem
Power Problem (3010)
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Patient Problem
Hypoglycemia (1912)
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Event Date 07/27/2022 |
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 date the incident occurred is unknown.The date entered in is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in 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 batter/power issue was reported with the adc device.The customer reported a defective battery stating the device "no longer loads." as a result, the customer experienced symptoms of hypoglycemia and was unable to self-treat.The customer had contact with a third-party who administered glucose as treatment.No further 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 batter/power issue was reported with the adc device.The customer reported a defective battery stating the device "no longer loads." as a result, the customer experienced symptoms of hypoglycemia and was unable to self-treat.The customer had contact with a third-party who administered glucose as treatment.No further 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.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 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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Search Alerts/Recalls
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