Model Number 75175-83 |
Device Problems
Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/04/2022 |
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.The date of event is unknown.The date entered 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 healthcare professional (hcp) had reported an error 3 message with the adc device and a replacement product was ordered.Due to a delay in the delivery of the replacement product, the hcp was unable to monitor the customer¿s glucose levels and the customer experienced a medical event.The customer received unspecified medical treatment due to the reported issue however, no further details were provided.There was no report of death or permanent injury 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 has 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 optium neo meter was reviewed and the dhrs showed the freestyle optium neo meter 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.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the previous report.Correction has been made.
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Event Description
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A healthcare professional (hcp) had reported an error 3 message with the adc device and a replacement product was ordered.Due to a delay in the delivery of the replacement product, the hcp was unable to monitor the customer¿s glucose levels and the customer experienced a medical event.The customer received unspecified medical treatment due to the reported issue however, no further details were 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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