Model Number 71992-01 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Chills (2191); Loss of consciousness (2418); Diaphoresis (2452)
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Event Date 06/22/2022 |
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 review) for the libre sensor and libre sensor kit 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 caregiver reported that a ¿replace sensor¿ error message was received with the adc device on the 1st day of wear.A glucose reading of 2.5 mmol/l was obtained on an unspecified device and the customer became hypoglycemic with symptoms of sweating, coldness, and a loss of consciousness.The customer was provided glucozage drink, toast, and tea with sugar by a third party for treatment.A post-treatment glucose reading of 4.7 mmol/l was reported and 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.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 3 (indicating the sensor was paired within the last 14 days).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) was performed and all results were within specification.No malfunction or product deficiency was identified.Therefore issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A caregiver reported that a ¿replace sensor¿ error message was received with the adc device on the 1st day of wear.A glucose reading of 2.5 mmol/l was obtained on an unspecified device and the customer became hypoglycemic with symptoms of sweating, coldness, and a loss of consciousness.The customer was provided glucozage drink, toast, and tea with sugar by a third party for treatment.A post-treatment glucose reading of 4.7 mmol/l was reported and 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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