Model Number 71940-01 |
Device Problem
High Readings (2459)
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Patient Problems
Fatigue (1849); Hypoglycemia (1912); Sweating (2444); Pallor (2468)
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Event Date 10/25/2019 |
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 high readings issue was reported with use of the adc freestyle libre sensor.Customer received a sensor scan result of 187 mg/dl and self-treated with omalog (dose unknown).Customer subsequently experienced symptoms described as "tired, sweaty and pale".Paramedics was called who obtained a reading of 62 mg/dl on the hcp meter and treated the customer with glucagon injection.No further treatment was required.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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(device mfg date) has been updated based on the returned product download.Sensor (b)(4) has been returned and investigated.Visual inspection has been performed and no issues were observed.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).Sensor plug was properly seated in the mount.Removed the sensor plug and inspected the plug assembly, no issues were observed.Sensor was reprogrammed and current was applied to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.
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Event Description
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A high readings issue was reported with use of the adc freestyle libre sensor.Customer received a sensor scan result of 187 mg/dl and self-treated with omalog (dose unknown).Customer subsequently experienced symptoms described as "tired, sweaty and pale".Paramedics was called who obtained a reading of 62 mg/dl on the hcp meter and treated the customer with glucagon injection.No further treatment was required.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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