Model Number 71732-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Fatigue (1849); Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452)
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Event Date 07/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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Extended investigation is pending at this time.A follow-up report will be submitted once additional information is obtained.The device manufacturing 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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An alarm issue was reported with the adc device in use with a samsung with android operating system version 2.8.4.9335.The low glucose alarm did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced symptoms described as sweat, dizziness, paleness, no strength and was unable to self-treat.Customer required third-party intervention who provided juice as treatment.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Smartphone compatibility with the use of freestyle librelink app and the samsung galaxy a33 5g device has not been tested at the time of the investigation.The compatibility guide states that abbott diabetes care has not assessed compatibility on phone/operating systems other than those listed.Attempted to replicate the user¿s complaint using similar configuration and successfully receive high and low glucose alarms on a samsung galaxy a52 (android 13, 2.8.4.9335) using a known good libre 2 sensor, and was unable to reproduce the complaint.Therefore, this complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An alarm issue was reported with the adc device in use with a samsung with android operating system version 2.8.4.9335.The low glucose alarm did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced symptoms described as sweat, dizziness, paleness, no strength and was unable to self-treat.Customer required third-party intervention who provided juice as treatment.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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