Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Loss of consciousness (2418); Diaphoresis (2452); Shaking/Tremors (2515)
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Event Date 08/27/2022 |
Event Type
Injury
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Event Description
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A customer reported experiencing bleeding upon application of the adc device.The customer indicated experiencing trembling, sweating, weakness of lower limbs, and lost consciousness, however, no third-party intervention was reported.There was no report of death or permanent injury associated with this event.
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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 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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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 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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Event Description
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A customer reported experiencing bleeding upon application of the adc device.The customer indicated experiencing trembling, sweating, weakness of lower limbs, and lost consciousness, however, no third-party intervention was reported.There was no report of death or permanent injury associated with this event.
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Event Description
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A customer reported experiencing bleeding upon application of the adc device.The customer indicated experiencing trembling, sweating, weakness of lower limbs, and lost consciousness, however, no third-party intervention was reported.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Sensor (b)(6)has been returned and investigated.Visual inspection has been performed on the sensor, no issue were observed.The sensor plug was properly seated.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.No malfunction or product deficiency was identified.Unable to perform further investigation due to partial product returned.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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