Model Number 71992-01 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Fatigue (1849); Hypoglycemia (1912); Chills (2191); Loss of consciousness (2418)
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Event Date 12/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.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.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle 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.Customer received higher sensor scan results when compared to a competitor brand meter and experienced symptoms described as chills, "mind went away", "no strength to stay upright", and a loss of consciousness.Customer had contact with paramedics who obtained a reading of 41 mg/dl on their device and transported the customer to a hospital where a reading of 70 mg/dl was obtained on a hospital meter.A urine examination was done and blood work was drawn, however no treatment was reported.There was no report of death or permanent injury associated with this event.
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Event Description
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A high reading issue was reported with the adc device.Customer received higher sensor scan results when compared to a competitor brand meter and experienced symptoms described as chills, "mind went away", "no strength to stay upright", and a loss of consciousness.Customer had contact with paramedics who obtained a reading of 41 mg/dl on their device and transported the customer to a hospital where a reading of 70 mg/dl was obtained on a hospital meter.A urine examination was done and blood work was drawn, however no treatment 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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Search Alerts/Recalls
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