Model Number 98100 |
Device Problem
High Readings (2459)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
|
Event Date 06/07/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot t10094n.No issues with d-dimer recovery were observed, lot performed properly.Manufacturing batch records for the lot were reviewed, lot met final release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
|
|
Event Description
|
Customer reported slightly elevated d-dimer results for one patient.Patient 1 on (b)(6) 2019- 1100ng/ml result data- female patient, chest x-ray done, no pe, cta chest pe with contrast done, negative for pe.An ascending thoracic aortic aneurysm discovered, surgical consult suggested.Atherosclerotic calcification seen, heart enlarged.No hemolysis of sample.Cta chest pe with contrast is mentioned in outcomes to adverse event.Reference range 0-600ng/ml.No critical value.No treatment administered/withheld based on the triage results.
|
|
Event Description
|
Customer reported observing elevated d-dimer results on the triage system for a patient.Patient was tested on triage and yielded a positive d-dimer result of 1100ng/ml.Sites' reference range is 0-600ng/ml.Customer stated no other coagulation tests were conducted.Customer stated patient had a chest x-ray done, no pe identified.Patient also had a "cta chest pe with contrast done, negative for pe".Patient was found to have an ascending thoracic aortic aneurysm and "atherosclerotic calcification seen, heart enlarged".
|
|
Manufacturer Narrative
|
Corrected: included patient gender in section a3.Dates listed in section b3, b5, b6 and d11 were incorrect in the initial mdr report.Updated patient code in h6.
|
|
Search Alerts/Recalls
|
|