Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problems
Discomfort (2330); Loss of consciousness (2418); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/16/2022 |
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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The customer reported their adc device was reading "lower values on scan than with a capillary test on hcp meter." customer reported a meter reading of 160mg/dl.User reported feeling "discomfort and sick." the patient reported a "skull injury" secondary to a loss of consciousness.User required treatment of "staples" from hcp.No further treatment was reported.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.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 will be submitted.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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The customer reported their adc device was reading "lower values on scan than with a capillary test on hcp meter." customer reported a meter reading of 160mg/dl.User reported feeling "discomfort and sick." the patient reported a "skull injury" secondary to a loss of consciousness.User required treatment of "staples" from hcp.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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