Model Number 71953-01 |
Device Problems
Device Alarm System (1012); No Audible Alarm (1019)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452)
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Event Date 12/22/2022 |
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 device mfg date 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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An alarm issue was reported with the adc device.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced "huge sweating, not approachable" and a loss of consciousness.The customer was unable to self-treat, requiring treatment of glucose pen injection by third-party.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.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.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.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.
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Event Description
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An alarm issue was reported with the adc device.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced "huge sweating, not approachable" and a loss of consciousness.The customer was unable to self-treat, requiring treatment of glucose pen injection by third-party.No further information was provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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