Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Hyperglycemia (1905); Dizziness (2194)
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Event Date 03/23/2024 |
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 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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A low reading issue was reported with the abbott diabetes care (adc) device.Customer reported unspecified low sensor reading compared to unspecified readings from a competitor brand meter.The customer self-treated with excess sugar and experienced hypoglycemic symptoms (dizziness) and subsequently, the customer required treatment with insulin (type/dose unknown) by their parents.No further information was provided by the customer.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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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 sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A low reading issue was reported with the abbott diabetes care (adc) device.Customer reported unspecified low sensor reading compared to unspecified readings from a competitor brand meter.The customer self-treated with excess sugar and experienced hypoglycemic symptoms (dizziness) and subsequently, the customer required treatment with insulin (type/dose unknown) by their parents.No further information was provided by the customer.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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