Model Number 72081-01 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problems
Hypoglycemia (1912); Discomfort (2330)
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Event Date 06/01/2023 |
Event Type
Injury
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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 and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered in section b3 is the date "in june" prior to when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced "not feeling well" and self measured blood glucose with result of "14-16" mmol/l prior to self-treating with insulin (type/dose unspecified), then took more insulin (type/dose unspecified).Customer later pulled over on drive home, experienced "almost unconscious", and bystanders called emergency services (es).Upon arrival, an es healthcare professional performed a blood glucose measurement with result of 2 mmol/l, prior to providing third-party treatment of "sugar/glucose-booster" for a diagnosis of hypoglycemia; post treatment blood glucose measurement was noted as "6-7" mmol/l.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software, and extraction was successful.Therefore, issue is not confirmed.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 kits were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced "not feeling well" and self measured blood glucose with result of "14-16" mmol/l prior to self-treating with insulin (type/dose unspecified), then took more insulin (type/dose unspecified).Customer later pulled over on drive home, experienced "almost unconscious", and bystanders called emergency services (es).Upon arrival, an es healthcare professional performed a blood glucose measurement with result of 2 mmol/l, prior to providing third-party treatment of "sugar/glucose-booster" for a diagnosis of hypoglycemia; post treatment blood glucose measurement was noted as "6-7" mmol/l.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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