Model Number 71992-01 |
Device Problem
High Readings (2459)
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Patient Problems
Hypoglycemia (1912); Hot Flashes/Flushes (2153); Malaise (2359)
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Event Date 08/11/2022 |
Event Type
Injury
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Event Description
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A complaint was received regarding unspecified higher sensor scans, than how they felt while wearing the adc device.As a result, on (b)(6) 2022, the customer could not speak correctly, could not move, felt sick, and had hot flashes and was provided orange juice and glucose tablet by a non-healthcare professional.No further information was provided.There was no report of death or permanent injury associated with this event.
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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 complaint was received regarding unspecified higher sensor scans, than how they felt while wearing the adc device.As a result, on (b)(6) 2022, the customer could not speak correctly, could not move, felt sick, and had hot flashes and was provided orange juice and glucose tablet by a non-healthcare professional.No further information was provided.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided for the sensor.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.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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