Catalog Number 03P89-24 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Information (3190)
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Event Date 01/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
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Event Description
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On 08/10/2018, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded suspected discrepant results on a patient.There was no patient information at the time of this report.The customer states the event occured on (b)(6) 2018.Return product is not available since pt/inr cartridges lot s17263b expired on 03/14/2018.(b)(6).There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
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Manufacturer Narrative
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Apoc incident # (b)(4).The investigation was completed on 09/20/2018.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Testing of retained cartridges from pt/inr cartridge lot s17263b could not be arranged prior to lot expiration.No deficiency has been identified for pt/inr cartridge lot s17263b.
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Search Alerts/Recalls
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