Model Number 71992-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Hot Flashes/Flushes (2153); Loss of consciousness (2418); Diaphoresis (2452)
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Event Date 03/26/2022 |
Event Type
Injury
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Event Description
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A customer reported that the low glucose alarm did not sound from the adc device and as a result, the customer was unable to obtain glucose scans.The customer experienced symptoms of heat, sweating, and a loss of consciousness, and was unable to self-treat.The customer was taken to a hospital where an iv was administered for the diagnosis of hypoglycemia.There was no report of death or permanent injury 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.All pertinent information available to abbott diabetes care has been submitted.
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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 as of this report.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.During the investigation, the user complaint was attempted to be replicated and was able to successfully receive high/low glucose alarms using android paired with a known good libre sensor.There were no issues identified with the librelink app.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported that the low glucose alarm did not sound from the adc device and as a result, the customer was unable to obtain glucose scans.The customer experienced symptoms of heat, sweating, and a loss of consciousness, and was unable to self-treat.The customer was taken to a hospital where an iv was administered for the diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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