Model Number 71992-01 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Hypoglycemia (1912)
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Event Date 06/20/2022 |
Event Type
Injury
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Manufacturer Narrative
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The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The date of event 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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported via webform an unspecified insertion issue with the adc device.Due to this issue, the customer was unable to monitor glucose and required treatment of juice, sugar, and/or food provided by a non-healthcare professional.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 the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and 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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Event Description
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A customer reported via webform an unspecified insertion issue with the adc device.Due to this issue, the customer was unable to monitor glucose and required treatment of juice, sugar, and/or food provided by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Applicator (b)(6) has been returned and investigated.Visual inspection has been performed on the applicator and no issues were observed.It is observed that the applicator was not fired correctly and sheath was locked.Observed sharp stuck inside sensor plug assembly sensor pack (b)(6) has been returned and investigated.Visual inspection was performed and no issues were observed.It is observed that the lid was completely peeled off.Sensor (b)(6) has been returned and investigated.Visual inspection has been performed and no issues were observed.The issue is not confirmed to use due to incorrect assembly method.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported via webform an unspecified insertion issue with the adc device.Due to this issue, the customer was unable to monitor glucose and required treatment of juice, sugar, and/or food provided by a non-healthcare professional.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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