Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Tachycardia (2095); Dizziness (2194); Convulsion/Seizure (4406)
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Event Date 10/23/2023 |
Event Type
Injury
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Event Description
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A "replace sensor" error message was reported with the adc device and the customer was unable to obtain readings from the sensor however, a glucose reading of 51 mg/dl was obtained on an unspecified meter.The customer experienced seizures, dizziness, and palpitations and was unable to self-treat, requiring third-party treatment of sugar water.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and 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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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 on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.Sim vivo testing (simulation of the electrical signal produced by the sensor tail) and poise voltage testing were performed and all results were within specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A "replace sensor" error message was reported with the adc device and the customer was unable to obtain readings from the sensor however, a glucose reading of 51 mg/dl was obtained on an unspecified meter.The customer experienced seizures, dizziness, and palpitations and was unable to self-treat, requiring third-party treatment of sugar water.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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