Model Number 71143-70 |
Device Problem
Packaging Problem (3007)
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Patient Problem
Hyperglycemia (1905)
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Event Date 01/03/2018 |
Event Type
Injury
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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.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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Customer reported a packaging issue, stating his adc freestyle precision neo meter kit contained an adc freestyle insulinx meter.Customer further reported he attempted to test using the meter and his freestyle precision neo test strips but was unsuccessful and had to be seen at a hospital.At the hospital, customer reported he was "given 3 injections, one of which he thinks is insulin".No additional information was provided as customer declined to continue troubleshooting.There was no report of death or permanent impairment associated with this event.
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Manufacturer Narrative
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No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhr(s) (device history review) for the freestyle insulinx meter and freestyle precision neo meter were reviewed and the dhr(s) showed the freestyle insulinx meter and freestyle precision neo meter passed all tests prior to release.The dhr (packout) report verified that the insulinx meter was packed 26-may-2016 and the freestyle precision neo meter was packed on 07-jul-2017, over a year apart from each other.There is no indication these meters were packed in the incorrect packages.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.This also serves as a correction report.Model no and pma/510(k) were incorrectly documented in the initial report.Both pma/510(k) and model no have been updated.
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Event Description
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Customer reported a packaging issue, stating his adc freestyle precision neo meter kit contained an adc freestyle insulinx meter.Customer further reported he attempted to test using the meter and his freestyle precision neo test strips but was unsuccessful and had to be seen at a hospital.At the hospital, customer reported he was "given 3 injections, one of which he thinks is insulin".No additional information was provided as customer declined to continue troubleshooting.There was no report of death or permanent impairment associated with this event.
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Search Alerts/Recalls
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