Model Number 58989 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Aortic Dissection (2491)
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Event Date 12/01/2019 |
Event Type
Death
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Manufacturer Narrative
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The event is still under investigation but it seems that the instrument performed as expected and that the origin of the defect is a human error (manual report of the results).Corporate complaint reference (b)(4).
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Event Description
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The patient experienced a type 1 aortic dissection.The technician manually released a ddi result to the lis as > 0.5 g/ml whereas the ddi was > 20.0 g/ml on the expert module (middleware).The > 0.5 g/ml result was interpreted as probably an acute thromboembolic event and the patient received a heparin drip within 24 hours of death.
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Manufacturer Narrative
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An analysis of the instrument data files shows that: the patient result on the instrument was > 20 g/ml.The quality control results before and after the result in question were within the stago the customer ranges.No problems with the analyzer occurred during the patient test.We have reviewed the event with the customer; she confirmed that it was a human error on the part of the technician, as manual reporting of the > 0.5 g/ml is a violation of their procedures.The customer took corrective actions, reviewed their policies and procedures and perform internal re-training.The stago system was not at fault in this case.Stago has completed its investigation into this matter.Stago reference number (b)(4).
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Search Alerts/Recalls
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