Model Number 71992-01 |
Device Problem
Low Readings (2460)
|
Patient Problems
Hyperglycemia (1905); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)
|
Event Date 12/18/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
At this time, product has not yet been returned and a valid serial number has not been provided.An 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 freestyle 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.The device manufacturing 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.
|
|
Event Description
|
A caller reported a low reading issue with the freestyle libre 2 sensor.The caller reported unspecified low reading, with customer developing symptoms of back pain and stomach cramps.The customer had contact with a healthcare professional and received treatment of insulin via pump (dose/type unknown).There was no report of death or permanent injury associated with this event.
|
|
Manufacturer Narrative
|
At this time, product has not yet been returned and a valid serial number has not been provided.An 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 freestyle 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.The device manufacturing 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.
|
|
Event Description
|
A caller reported a low reading issue with the freestyle libre 2 sensor.The caller reported unspecified low reading, with customer developing symptoms of back pain and stomach cramps.The customer had contact with a healthcare professional and received treatment of insulin via pump (dose/type unknown).There was no report of death or permanent injury associated with this event.
|
|
Search Alerts/Recalls
|