Model Number 71992-01 |
Device Problem
High Readings (2459)
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Patient Problems
Hypoglycemia (1912); Discomfort (2330); Malaise (2359); Loss of consciousness (2418)
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Event Date 08/12/2022 |
Event Type
Injury
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Event Description
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A high reading issue was reported with the adc device.A caller reported receiving an unspecified high sensor scan on the sensor when compared to a built-in meter.The customer felt sick and experienced discomfort and a loss of consciousness and was treated with sugar water by a non-healthcare professional.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.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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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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit 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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A high reading issue was reported with the adc device.A caller reported receiving an unspecified high sensor scan on the sensor when compared to a built-in meter.The customer felt sick and experienced discomfort and a loss of consciousness and was treated with sugar water by a non-healthcare professional.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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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).Inspected the plug assembly, no issues 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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A high reading issue was reported with the adc device.A caller reported receiving an unspecified high sensor scan on the sensor when compared to a built-in meter.The customer felt sick and experienced discomfort and a loss of consciousness and was treated with sugar water by a non-healthcare professional.No further information was reported.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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