Description of Event or Problem · 0
MANUFACTURE: TRINITY BIOTECH INSTRUMENT: PREMIER HB9210 SUMMARY: THERE IS A DISCREPANCY BETWEEN THE CALIBRATOR MATERIAL PACKAGE INSERT AND THE PROCEDURE/INSTRUCTION MANUAL FOR THE INSTRUMENT. IN 2020 THE PROCEDURE MANUAL 24TH REVISION UPDATE HAD LANGUAGE IN CHAPTER 6 PAGE 5 CHANGED TO NO LONGER ALLOW FOR CALIBRATOR SET POINTS BE DETERMINED BY USER DEFINED. PROCEDURE MANUAL 23RD REVISION COPYRIGHTED IN 2017 DID ALLOW FOR USER-DEFINED SET POINTS. THE CALIBRATOR PACKAGE INSERT VERBIAGE DID NOT CHANGE INCLUDING THE MOST RECENT REVISION IN MARCH 2024. PACKAGE INSERT FOR CALIBRATION MATERIAL FROM TRINITY BIOTECH STATES. "IT IS RECOMMENDED THAT EACH LABORATORY ESTABLISH ITS OWN MEANS AND ACCEPTABLE RANGES AND USE THOSE PROVIDED ONLY AS GUIDES. WHEN ASSAYED BY THE TRINITY BIOTECH HPLC AFFINITY METHOD, THE RESULTS ON EACH TRINITY BIOTECH ANALYZER SHOULD FALL WITHIN THESE LIMITS. "PROCEDURE MANUAL VERSION 24 HAD VERBIAGE CHANGED TO STATE: TRINITY BIOTECH DOES NOT APPROVE THE USE OF 3RD-PARTY (NOT SUPPLIED BY TRINITY BIOTECH) HGA1C CALIBRATOR MATERIAL AND/OR USER-DETERMINED HBA1C CALIBRATOR SET POINTS. 23RD VERSION STATED:" FOR CUSTOMERS USING THIRD-PARTY HBA1C CALIBRATORS AND/OR CONTROLS, VALUES CAN BE ENTERED MANUALLY FOR THE USER-DETERMINED SET POINTS AND ARRANGE. (B)(6) PATHOLOGY DID NOT RECEIVE ANY COMMUNICATION REGARDING CHANGES OR DISCREPANCY AT ANY POINT. ADDITIONAL INFORMATION: DURING THE VALIDATION OF NEW EQUIPMENT INSTALLED AT (B)(6), THE METHOD CORRELATION STUDIES BETWEEN THESE LABS AND THE LEGACY INSTRUMENT AT (B)(6) FAILED. THE OBSERVED BIAS HAD VARIABLE VALUES UP TO 13% TEA, THIS WAS HIGHER THAN WHAT WAS EXPECTED. A MEETING WAS HELD ON (B)(6) 2026 BETWEEN DR. (B)(6), (B)(6) AND (B)(6) WITH (B)(6) FROM TRINITY BIOTECH. HE STATED THAT HE OBSERVED POSITIVE BIAS DURING THE PM PERFORMED AT (B)(6) ON (B)(6) 2026. THIS CAUSED HIS PM TO FAIL THE LINEARITY AND ACCURACY TESTS. HE BELIEVED THE REASON FOR THIS WAS DUE TO THE CALIBRATOR SET POINTS ON THE INSTRUMENTS AT (B)(6). (B)(6) STATED THAT HE HAD TO USE THE COMPANY MANUFACTURING APPROVED RANGES (SET POINTS) TO PASS LINEARITY AND ACCURACY. ONCE THE PM PASSED, HE RETURNED THE SET POINTS TO THEIR ORIGINAL SETTINGS. HE STATED THAT (B)(6) WAS ALERTED TO THIS, HOWEVER, NO GUIDANCE WAS GIVEN TO ADJUST THE SET POINTS BECAUSE HE WAS AWARE THAT THE LAB WAS SETTING THEIR OWN RANGES FOR THE CALIBRATOR AND SOME CUSTOMERS DID THAT. HE ALSO STATED THAT THIS WAS AN OUTDATED PRACTICE. TO PROCEED WITH THE VALIDATION OF THE INSTRUMENTS, HE RECOMMENDED THAT THE SET POINTS AT (B)(6) BE CHANGED TO MATCH PACKAGE INSERT RECOMMENDED SET POINTS. UPON INVESTIGATION, IT WAS DISCOVERED THAT (B)(6) WAS FOLLOWING THE CALIBRATOR PACKAGE INSERT RECOMMENDATION TO ESTABLISH LABORATORY RANGES (SET POINTS).