Model Number 71992-01 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Diabetic Ketoacidosis (2364)
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Event Date 07/24/2023 |
Event Type
Injury
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Event Description
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An adhesive issue was reported with the adc sensor.The sensor prematurely detached and the customer was unable to obtain readings.As a result, customer experienced got ketones in her urine and presented to the local hospital where no third-party treatment was reported.The customer reportedly self-treated with unspecified treatment.No additional treatment information was provided.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.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.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.No physical damage was observed on the returned sensor patch and no issues were observed with the returned sensor adhesive.No malfunction or product deficiency has been identified.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for libre sensor kits were reviewed and the dhrs showed the 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 adhesive issue was reported with the adc sensor.The sensor prematurely detached and the customer was unable to obtain readings.As a result, customer experienced got ketones in her urine and presented to the local hospital where no third-party treatment was reported.The customer reportedly self-treated with unspecified treatment.No additional treatment information was provided.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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