Model Number 71992-01 |
Device Problem
High Readings (2459)
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Patient Problems
Hypoglycemia (1912); Sweating (2444); Palpitations (2467); Confusion/ Disorientation (2553)
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Event Date 09/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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The reported product is not expected to be returned as the customer discarded the product.A follow-up report will be filed if product is returned or additional information is obtained.The device mfg date is unknown.The date entered in section h4 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 the use of the adc freestyle libre 2 sensor.A healthcare professional, who is a customer reported receiving a high sensor reading of 144 mg/dl as compared to a competitor meter reading of 59 mg/dl.The customer reported becoming hypoglycemic and experienced symptoms described as ¿sweat, breakout, rapid heart rate, coordination problems, and confusion¿ and was unable to self self-treat.The customer¿s wife treated him with ¿grape sugar¿ and no further treatment was required.There was no report of death or permanent impairment associated with this event.
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Event Description
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A high readings issue was reported with the use of the adc freestyle libre 2 sensor.A healthcare professional, who is a customer reported receiving a high sensor reading of 144 mg/dl as compared to a competitor meter reading of 59 mg/dl.The customer reported becoming hypoglycemic and experienced symptoms described as ¿sweat, breakout, rapid heart rate, coordination problems, and confusion¿ and was unable to self self-treat.The customer¿s wife treated him with ¿grape sugar¿ and 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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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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Search Alerts/Recalls
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