Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Hypoglycemia (1912); Dizziness (2194); Discomfort (2330)
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Event Date 08/30/2023 |
Event Type
Injury
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Event Description
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An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached after two days of wear and the customer was unable to obtain readings or monitor glucose levels.As a result, customer experienced "dizziness", "discomfort", and was unable to self-treat, requiring contact with a healthcare professional (hcp).The hcp performed a blood glucose measurement with result of 1.56 mmol/l, prior to providing third-party treatment of "glucose injection" (type/dose unspecified) and also reduced customer's insulin dose (dosages unspecified).There was no report of death or permanent injury associated with this event.
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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 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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An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached after two days of wear and the customer was unable to obtain readings or monitor glucose levels.As a result, customer experienced "dizziness", "discomfort", and was unable to self-treat, requiring contact with a healthcare professional (hcp).The hcp performed a blood glucose measurement with result of 1.56 mmol/l, prior to providing third-party treatment of "glucose injection" (type/dose unspecified) and also reduced customer's insulin dose (dosages unspecified).There was no report of death or permanent injury 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.The dhrs (device history review) for libre sensor kits were reviewed and the dhrs showed the libre sensor kits passed all tests prior to release.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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