ELECSYS FOLATE III

Additional Manufacturer Narrative

THE QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FOLATE III RESULTS FOR 10 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR ANALYZER. THE CUSTOMER QUESTIONED THE LOW INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' CLINICAL PICTURES WHICH PROMPTED THEM TO REPEAT THE SAMPLES ON A COMPETITOR ANALYZER. FOR SAMPLE 1, THE FOLATE RESULT WAS 2.6 NMOL/L AND WITH THE COMPETITOR METHOD THE RESULT WAS 5.675 NMOL/L. FOR SAMPLE 2, THE FOLATE RESULT WAS 3.22 NMOL/L AND WITH THE COMPETITOR METHOD THE RESULT WAS 5.675 NMOL/L. FOR SAMPLE 3, THE FOLATE RESULT WAS 3.9 NMOL/L AND WITH THE COMPETITOR METHOD THE RESULT WAS 6.129 NMOL/L. FOR SAMPLE 4, THE FOLATE RESULT WAS 4.34 NMOL/L AND WITH THE COMPETITOR METHOD THE RESULT WAS 7.037 NMOL/L. FOR SAMPLE 5, THE FOLATE RESULT WAS 3.4 NMOL/L AND WITH THE COMPETITOR METHOD THE RESULT WAS 7.264 NMOL/L. FOR SAMPLE 6, THE FOLATE RESULT WAS 4.75 NMOL/L AND WITH THE COMPETITOR METHOD THE RESULT WAS 7.491 NMOL/L. FOR SAMPLE 7, THE FOLATE RESULT WAS 7.29 NMOL/L AND WITH THE COMPETITOR METHOD THE RESULT WAS 11.35 NMOL/L. FOR SAMPLE 8, THE FOLATE RESULT WAS 7.32 NMOL/L AND WITH THE COMPETITOR METHOD THE RESULT WAS 11.35 NMOL/L. FOR SAMPLE 9, THE FOLATE RESULT WAS 28.7 NMOL/L AND WITH THE COMPETITOR METHOD THE RESULT WAS 43.811 NMOL/L. FOR SAMPLE 10, THE FOLATE RESULT WAS 27.3 NMOL/L AND WITH THE COMPETITOR METHOD THE RESULT WAS 44.492 NMOL/L.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.