Model Number 71940-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Fall (1848); Hyperglycemia (1905); Pain (1994); Vomiting (2144)
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Event Date 09/01/2021 |
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 low readings issue was reported with the adc freestyle libre 2 sensor.Customer received unspecified a reading of 178 mg/dl on the sensor scan which was lower when compared to a lab result.Customer had a fall and experienced symptoms described as "blue eye, vomiting, bump, pain in the wrist" and had contact with healthcare provider.A lab glucose reading of 780 mg/dl was obtained and customer was diagnosed with hyperglycemia, requiring unspecified treatment for hyperglycemia and wound care.There was no report of death or permanent impairment 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.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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Event Description
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A low readings issue was reported with the adc freestyle libre 2 sensor.Customer received unspecified a reading of 178 mg/dl on the sensor scan which was lower when compared to a lab result.Customer had a fall and experienced symptoms described as "blue eye, vomiting, bump, pain in the wrist" and had contact with healthcare provider.A lab glucose reading of 780 mg/dl was obtained and customer was diagnosed with hyperglycemia, requiring unspecified treatment for hyperglycemia and wound care.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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