ELECSYS BRAHMS PCT

Additional Manufacturer Narrative

(B)(6). (B)(4).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS BRAHMS PCT (PCT) THAT DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL PICTURE. THE PATIENT¿S PCT RESULTS HAVE BEEN CONSISTENTLY OVER 100 NG/ML. THE RESULTS HAVE BEEN REPORTED OUTSIDE OF THE LABORATORY WHERE THE HIGH RESULTS WERE QUESTIONED BY THE MEDICAL DOCTOR. THE HIGH RESULTS WERE QUESTIONED AS THE PATIENT DOES NOT HAVE SEPSIS AND THE PATIENT¿S CRP RESULTS WERE LOW. A HIGH PCT RESULT CAN ALSO BE CAUSED BY MEDULLARY THYROID CARCINOMA (MTC). THIS DISEASE HAS BEEN RULED OUT FOR THE PATIENT BY MEASURING CALCITONIN RESULTS WHICH WERE LOW. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE INSTRUMENT TYPE AND SERIAL NUMBER WERE NOT PROVIDED.

Additional Manufacturer Narrative

LOT NUMBER AND EXPIRATION DATE WERE UPDATED. THE INSTRUMENT WAS A COBAS E 411 IMMUNOASSAY ANALYZER WITH A SERIAL NUMBER OF (B)(4). A NEW SAMPLE WAS OBTAINED ON (B)(6) 2018 AND THE PCT RESULT WAS 91.1 NG/ML AT THE CUSTOMER SITE. IT WAS CLARIFIED THAT WHEN ATTEMPTS WERE MADE TO TEST THIS PATIENT PRIOR TO THE RESULT ON (B)(6) 2018, THE RESULT ON (B)(6) 2018 WAS >100 NG/ML WITH A DATA FLAG. THE PATIENT HAS BEEN IN THE HOSPITAL SINCE (B)(6) 2017 DUE TO SEVERE PANCREATITIS INCLUDING SEPTIC SHOCK AS WELL AS ORGAN FAILURE. PCT WAS HIGH FROM THE BEGINNING WITH ELECSYS PCT VALUES ALWAYS >100 NG/ML WITH A DATA FLAG. CRP WAS ALSO HIGH, BUT SINCE THE LAST WEEK IN (B)(6) 2018, IT HAS DECREASED TO 30 MG/L. SINCE THE LAST WEEK IN (B)(6) 2018, THE PATIENT IS AWAKE AND MOBILE, BUT IS STILL HOSPITALIZED; THE PATIENT IS NOT RECEIVING CATECHOLAMINES ANY LONGER. THE PATIENT HAS DELIRIC SYNDROME ("DELIRANTES SYNDROME") INCLUDING POSITIVE BLOOD CULTURES WHICH DO NOT CORRELATE WITH THE CLINICAL PICTURE SINCE THE PATIENT SHOWS NO FEVER. THE PATIENT DOES SUFFER FROM ONGOING INTESTINAL FISTULAS. THE HIGH PCT VALUES TRIGGERED A CHANGE IN TREATMENT DURING THE TIME THE PATIENT WAS SUFFERING FROM CLINICAL SEPTIC SHOCK. THE PANCREATITIS WAS TREATED CONSERVATIVELY FOR AWHILE AND THE FIRST OPERATIONS STARTED AT THE END OF (B)(6) 2017. THESE OPERATIONS LED TO THE INTESTINAL FISTULAS.

Additional Manufacturer Narrative

FROM THE DATA PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE SAMPLE WAS TESTED FOR INTERFERING SUBSTANCES AND NONE WERE FOUND. THE HIGH PCT VALUE WAS CONFIRMED AT AN EXTERNAL LABORATORY WITH A SIEMENS CENTAUR ANALYZER.

Additional Manufacturer Narrative

THE CUSTOMER ANALYZED ANOTHER SAMPLE FROM THE PATIENT AFTER THEIR HEALTH HAD IMPROVED. THE PCT RESULT WAS 50 NG/ML FROM THIS NEW SAMPLE AND WAS BELIEVABLE TO BE IMPLAUSIBLE. THE PATIENT NO LONGER HAD A FEVER AND NO OBVIOUS INFLAMMATION. THE PATIENT STILL HAD INTESTINAL FISTULAS. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL DEPARTMENT AS THEY ARE NOW MOBILE. THE PATIENT HAD A NORMAL CRP RESULT OF 3 MG/L AND A LEUKOCYTE COUNT OF 12,000.

Additional Manufacturer Narrative

THE PATIENT SAMPLE FROM (B)(6) 2018 WAS SUBMITTED FOR INVESTIGATION. THE SAMPLE WAS TESTED BY THE CENTAUR METHOD WITH A PCT RESULT OF 61.24 NG/ML WHICH WAS LOWER THAN THE RESULT FROM THE ROCHE METHOD (91.1 NG/ML) HOWEVER, THE CLINICAL CONCLUSION WOULD HAVE BEEN THE SAME FOR BOTH RESULTS. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.