Model Number 71992-01 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
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Event Date 03/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre sensor kit 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 caller reported that the adc device applicator needle was bent, and therefore the sensor did not properly insert.As a result of this, the customer experienced seizure and loss of consciousness due to hypoglycemia.It was reported that the customer received treatment from both non-healthcare professional and healthcare professionals (ambulance); however, no treatment details were provided.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.The sensor plug is properly seated and no physical damage was observed.Watermark was not observed at the base of the sensor tail.Visual inspection has been performed on the sensor plug assembly.Visual inspection has been performed on the sensor pack and observed damaged transition features and lid was completely peeled off.Visual inspection has been performed on the applicator, no issues were observed and applicator had fired correctly.Therefore, 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 caller reported that the adc device applicator needle was bent, and therefore the sensor did not properly insert.As a result of this, the customer experienced seizure and loss of consciousness due to hypoglycemia.It was reported that the customer received treatment from both non-healthcare professional and healthcare professionals (ambulance); however, no treatment details were provided.There was no report of death or permanent injury associated with this event.
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Search Alerts/Recalls
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