Model Number 71940-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Paralysis (1997); Weakness (2145); Discomfort (2330); Diabetic Ketoacidosis (2364)
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Event Date 05/29/2019 |
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 in section 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 customer reported a low readings issue with the adc freestyle libre, reporting that the sensor scan showed a normal reading, but she was hospitalized the next day due to diabetic ketoacidosis.Sensor scan results of "6.X mmol/l" were compared to competitor blood glucose meter results of "12-14 mmol/l".On (b)(6) 2019 the customer experienced symptoms of weakness, paralysis, and discomfort, so she was taken to the hospital where she was diagnosed with dka and treated with intravenous re-hydration and unspecified medication.It was further noted that the customer is now in stable condition.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 was returned for this complaint.Extended investigation was performed and determined that there was no indication that the product did not meet specification.The reported complaint does not pertain to libre readers.Therefore, no further investigation into the reader will be required.Dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the 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.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 customer reported a low readings issue with the adc freestyle libre, reporting that the sensor scan showed a normal reading, but she was hospitalized the next day due to diabetic ketoacidosis.Sensor scan results of "6.X mmol/l" were compared to competitor blood glucose meter results of "12-14 mmol/l".On (b)(6)2019 the customer experienced symptoms of weakness, paralysis, and discomfort, so she was taken to the hospital where she was diagnosed with dka and treated with intravenous re-hydration and unspecified medication.It was further noted that the customer is now in stable condition.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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