Model Number 71992-01 |
Device Problem
Low Readings (2460)
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Patient Problem
Diabetic Ketoacidosis (2364)
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Event Date 04/18/2023 |
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 date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in section h4 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 use of the abbott diabetes care (adc) device.Customer received lower sensor scan results when compared to readings obtained on unspecified meter.As a result, customer "freaked out" and contacted a healthcare professional (hcp) who advised them to go to the emergency room (er).At the er, the customer was diagnosed with diabetic ketoacidosis (dka) and received unspecified third party treatment.There was no report of death or permanent impairment associated with this event.
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Event Description
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A low readings issue was reported with use of the abbott diabetes care (adc) device.Customer received lower sensor scan results when compared to readings obtained on unspecified meter.As a result, customer "freaked out" and contacted a healthcare professional (hcp) who advised them to go to the emergency room (er).At the er, the customer was diagnosed with diabetic ketoacidosis (dka) and received unspecified third party treatment.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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Search Alerts/Recalls
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