Model Number 71940-01 |
Device Problem
High Readings (2459)
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Patient Problems
Fainting (1847); Hypoglycemia (1912); Weakness (2145); Loss of consciousness (2418); Sweating (2444)
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Event Date 02/19/2019 |
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 mother reported that her son, the customer, received higher readings while wearing the adc freestyle libre senor.The mother scanned the sensor on (b)(6) 2019 and obtained an 82mg/dl at 8 am, 77mg/dl at 8:47 am, and later at 16:40 obtained 70mg/dl.At that time the mother reported the customer became weak, sweaty with dark circles around his eyes, and fainted, losing consciousness.The customer was treated for hypoglycemia by an hcp in a clinic with "syrup, " sugar, and a slice of bread.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 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 freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre 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.If the product is returned, the case will be re-opened and a physical investigation will be performed.
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Event Description
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A mother reported that her son, the customer, received higher readings while wearing the adc freestyle libre senor.The mother scanned the sensor on (b)(6) 2019 and obtained an 82mg/dl at 8 am, 77mg/dl at 8:47 am, and later at 16:40 obtained 70mg/dl.At that time the mother reported the customer became weak, sweaty with dark circles around his eyes, and fainted, losing consciousness.The customer was treated for hypoglycemia by an hcp in a clinic with "syrup, " sugar, and a slice of bread.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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