Model Number 71940-01 |
Device Problem
High Readings (2459)
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Patient Problems
Fainting (1847); Hypoglycemia (1912); Loss of consciousness (2418)
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Event Date 06/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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The has been disposed and not expected 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 pharmacist reported a customer obtained higher readings when scanning the adc freestyle libre sensor compared to an hcp meter.On (b)(6) 2019, the customer obtained sensor scans of 4.8mmol/l and 5mmol/l but subsequently fainted and lost consciousness.Emergency services were called and upon arrival, a blood glucose of 1.5mmo/l was obtained on the hcp meter compared to an additional sensor scan of 9mmol/l.The customer received a glucose injection for the treatment of hypoglycemia.There was no report of death or permanent injury associated with this event.
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Event Description
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A pharmacist reported a customer obtained higher readings when scanning the adc freestyle libre sensor compared to an hcp meter.On (b)(6) 2019, the customer obtained sensor scans of 4.8mmol/l and 5mmol/l but subsequently fainted and lost consciousness.Emergency services were called and upon arrival, a blood glucose of 1.5mmo/l was obtained on the hcp meter compared to an additional sensor scan of 9mmol/l.The customer received a glucose injection for the treatment of hypoglycemia.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Updated sensor serial unknown to (b)(4).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.The reported complaint does not pertain to the freestyle libre reader.Therefore no further investigation into the reader is required.Dhrs (device history review) 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.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.
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Search Alerts/Recalls
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