Model Number 71992-01 |
Device Problems
Difficult to Insert (1316); Material Twisted/Bent (2981)
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Patient Problems
Hyperglycemia (1905); Pain (1994); Convulsion/Seizure (4406)
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Event Date 09/30/2021 |
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.Dhrs (device history record) 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 custom reported that upon attempting to apply the freestyle libre 2 sensor, the sensor tip was bent and therefore did not penetrate the skin.The customer felt pain at the sensor site and subsequently experienced seizure.The customer was able to self-treat with glucose (via drinks and carbohydrates) and a doctor was called to her home.The doctor examined the sensor site and additionally administered insulin for treatment.No further information was 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.Visual inspection has been performed and no issues were observed.Visual inspection was performed on the sensor plug assembly and observed sharp stuck inside.A watermark at the base of the tail was observed, this is an indication that the sensor was properly inserted.The sensor applicator and sensor pack were not returned, therefore no further investigation can be conducted for this particular complaint.If additional product is returned, an investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A custom reported that upon attempting to apply the freestyle libre 2 sensor, the sensor tip was bent and therefore did not penetrate the skin.The customer felt pain at the sensor site and subsequently experienced seizure.The customer was able to self-treat with glucose (via drinks and carbohydrates) and a doctor was called to her home.The doctor examined the sensor site and additionally administered insulin for treatment.No further information was 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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