Model Number 71953-01 |
Device Problem
Self-Activation or Keying (1557)
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Patient Problems
Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452)
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Event Date 09/29/2023 |
Event Type
Injury
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Event Description
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A power issue was reported with the adc device.The meter cycled without pressing any buttons and customer was unable to obtain readings.As a result customer experienced symptoms described as "dizzy, sweats and fall.Customer was treated with "sugar drink" by healthcare professional.Customer did not report any treatment for the fall, stated "healing of leg".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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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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle libre reader were reviewed and the dhrs showed the freestyle libre reader 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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Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the reader and no issues were observed.Built-in reader test was performed and all results were within specification.All functions were cycling normally.Therefore, the 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 power issue was reported with the adc device.The meter cycled without pressing any buttons and customer was unable to obtain readings.As a result customer experienced symptoms described as "dizzy, sweats and fall.Customer was treated with "sugar drink" by healthcare professional.Customer did not report any treatment for the fall, stated "healing of leg".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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