Model Number 71992-01 |
Device Problem
High Readings (2459)
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Patient Problems
Hypoglycemia (1912); Hot Flashes/Flushes (2153)
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Event Date 11/09/2022 |
Event Type
Injury
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Manufacturer Narrative
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At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the libre sensor and libre sensor kit were reviewed and the dhrs showed the 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 caregiver reported that an unspecified high scan was received on the sensor when compared to a competitor meter.The customer experienced symptoms described as ¿feeling strange¿, weak legs, feeling hot, and unwell¿.The customer was provided glucose gel by the mother for treatment and no 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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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 caregiver reported that an unspecified high scan was received on the sensor when compared to a competitor meter.The customer experienced symptoms described as ¿feeling strange¿, weak legs, feeling hot, and unwell¿.The customer was provided glucose gel by the mother for treatment and no 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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