Model Number 71953-01 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Hypoglycemia (1912); Coma (2417); Loss of consciousness (2418)
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Event Date 08/17/2023 |
Event Type
Injury
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Event Description
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An alarm issue was reported with the adc device.The customer reported the low alarm did not sound and as a result, the customer experienced symptoms described as a diabetic coma, a loss of consciousness and was unable to self-treat.Customer had contact with a healthcare professional (paramedics) who provided food and sugar as treatment for the diagnosis of hypoglycemia.No further information was reported.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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Event Description
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An alarm issue was reported with the adc device.The customer reported the low alarm did not sound and as a result, the customer experienced symptoms described as a diabetic coma, a loss of consciousness and was unable to self-treat.Customer had contact with a healthcare professional (paramedics) who provided food and sugar as treatment for the diagnosis of hypoglycemia.No further information was reported.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Reader (b)(6) has been returned and investigated.Visually inspected the reader and no issues were observed.The isf (interstitial fluid) log was downloaded using approved software.An analysis of the glucose value graph was performed and all alarms presented were for glucose values outside of the threshold range.A secure-1 was cloned to address the event log that observed.No malfunction or product deficiency was identified.Extended investigation has been performed for the reported complaint and 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.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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