TRIAGE PROFILER SOB PANEL
Received Jan 15, 2016 · Event occurred Jan 8, 2016
Report 2027969-2016-00030 · MDR key 5370750
Device
Product problems
- False Positive Result
- Incorrect, Inadequate or Imprecise Result or Readings
- False Positive Result
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT DEVICE CODE (CONTINUED): DAP, DDR, JHX AND MMI. INVESTIGATION/CONCLUSION: THE PHYSICIAN'S OFFICE WAS UNABLE TO PROVIDE A LOT NUMBER OR RETURN ANY PRODUCTS FOR INVESTIGATION. SINCE THE PRODUCT(S) ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED AND FURTHER INVESTIGATION WAS NOT POSSIBLE. ALL COMPLAINTS ARE REVIEWED, TRACKED AND TRENDED. ALL COMPLAINTS ARE REVIEWED, TRACKED AND TRENDED.
Description of Event or Problem
THE EVENT OCCURRED IN (B)(6). A PATIENT WAS TESTED IN THE PHYSICIAN'S OFFICE WITH THE TRIAGE SOB PANEL AND RECEIVED A D-DIMER RESULT OF 3000 NG/ML. THE PATIENT WAS LATER TESTED AT THE HOSPITAL AND THE LABORATORY D-DIMER RESULT WAS NEGATIVE AT 300 NG/ML. A COMPUTERIZED TOMOGRAPHY (CT) WAS PERFORMED AND A TUMOR WAS FOUND. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)
Additional Manufacturer Narrative
CORRECTIONS: REPORT SOURCE CORRECTED TO REMOVE COMPANY REPRESENTATIVE AND INCLUDE CONSUMER.