Model Number 71953-01 |
Device Problem
No Device Output (1435)
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Patient Problem
Dizziness (2194)
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Event Date 09/14/2023 |
Event Type
Injury
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Event Description
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A testing issue was reported with the adc reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.As a result, customer experienced dizziness and shambles.The customer reported unspecified treatment from third-party due to this issue.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 mfg 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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Event Description
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A testing issue was reported with the adc reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.As a result, customer experienced dizziness and shambles.The customer reported unspecified treatment from third-party due to this issue.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product was returned for this complaint.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 the libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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