Model Number 71940-01 |
Device Problem
Low Readings (2460)
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Patient Problem
Hyperglycemia (1905)
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Event Date 08/24/2016 |
Event Type
Injury
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Manufacturer Narrative
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The reported product is not expected to be returned as reporter indicated the device was discarded.A follow-up report will be filed if product is returned or additional information is obtained.The date of event is unknown.The date entered is based on the report of "4 years ago".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 low readings issue was reported with the freestyle libre sensor.Customer reported that four years ago, she received low sensor scans and being hospitalized.No symptoms were reported, but in the hospital, customer was treated with glucose based on the sensor scan results received.Post-treatment of glucose, a reading of 350 mg/dl was obtained on the hcp meter compared to a sensor scan result of 60 mg/dl, and customer was administered insulin for treatment.No further details were provided.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 and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.
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Event Description
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A low readings issue was reported with the freestyle libre sensor.Customer reported that four years ago, she received low sensor scans and being hospitalized.No symptoms were reported, but in the hospital, customer was treated with glucose based on the sensor scan results received.Post-treatment of glucose, a reading of 350 mg/dl was obtained on the hcp meter compared to a sensor scan result of 60 mg/dl, and customer was administered insulin for treatment.No further details were provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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