Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Nausea (1970); Seizures (2063); Loss of consciousness (2418)
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Event Date 10/17/2020 |
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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A low readings issue was reported with the adc freestyle libre 2 sensor.The customer received unspecified low readings as compared to readings obtained on a competitor brand meter.The customer experienced "swollen tongue", nausea, seizure, and subsequently lost consciousness.The customer had contact with a healthcare provider and was administered an unspecified infusion.No further information was provided.There was no report of death or permanent injury associated with this event.
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Event Description
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A low readings issue was reported with the adc freestyle libre 2 sensor.The customer received unspecified low readings as compared to readings obtained on a competitor brand meter.The customer experienced "swollen tongue", nausea, seizure, and subsequently lost consciousness.The customer had contact with a healthcare provider and was administered an unspecified infusion.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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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.
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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 linearity testing while in the test fixture.All results were within specification.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 low readings issue was reported with the adc freestyle libre 2 sensor.The customer received unspecified low readings as compared to readings obtained on a competitor brand meter.The customer experienced "swollen tongue", nausea, seizure, and subsequently lost consciousness.The customer had contact with a healthcare provider and was administered an unspecified infusion.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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