Model Number 71992-01 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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This is an initial final report. this issue does not meet reportability criteria; however, it is being reported to the fda as the complaint was received via user report.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.Two different devices, freestyle libre 14 day and freestyle libre 2, were reported under mw5104622.This report covers the freestyle libre 2 device.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Abbott diabetes care received a medwatch report which reported the following information: a customer reported an issue with the freestyle libre sensor (14 day) and freestyle libre 2 sensor packaging, stating that due to the similarity between the device packaging, pharmacies have mistakenly dispensed the incorrect product.The customer additionally stated that some healthcare professionals are not aware the two devices are not interchangeable, and suggested a packaging or product name change.There was no report of adverse event or third-party intervention required due to the reported issue.Based on the information provided, there was no report of serious injury associated with this event.
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Search Alerts/Recalls
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