TINA-QUANT HBALC GEN. 3

Additional Manufacturer Narrative

THE C501 MODULE SERIAL NUMBER WAS (B)(6). THE RATIO DEFINITION FOR MMOL/MOL HBA1C AND % HBA1C CALCULATION IS AS FOLLOWS: PROTOCOL 1 (MMOL/MOL HBA1C ACC. TO IFCC): ABBREVIATED RATIO NAME RWI3. EQUATION(A1-W3/HB-W3) × 1000 - UNIT MMOL/MOL. THE MMOL/MOL HBA1C VALUES ACCORDING TO PROTOCOL 1 (IFCC) MUST BE MANUALLY CALCULATED ACCORDING TO THE ABOVE EQUATION. A CALCULATED TEST WITH THE FORMULA IN PROTOCOL 1 CAN BE PROGRAMMED ON THE INSTRUMENT. THE RATIO FOR HBA1C (MMOL/MOL HBA1C ACC. TO IFCC AND % HBA1C ACC. TO DCCT/NGSP) WILL BE AUTOMATICALLY CALCULATED AFTER THE RESULT OUTPUT OF BOTH TESTS. PROTOCOL 2 (% HBA1C ACC. TO DCCT/NGSP): ABBREVIATED RATIO NAME RWD3 (891) EQUATION(A1-W3/HBW3) × 91.5 + 2.15 - UNIT %. PROTOCOL 2 IS ALREADY IMPLEMENTED IN WHEN USING APPLICATION ACN 891 OF THE ASSAY. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION FOR THE INVESTIGATION. THERE IS NO INDICATION OF A GENERAL PRODUCT PROBLEM AND THERE IS NO INFORMATION TO SUGGEST THERE ARE ANY GENERAL ISSUES WITH THE WAY THE HBA1C TEST ON THE C501 MODULE CALCULATES THE RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE COBAS 6000 C 501 MODULE SERIAL NUMBER WAS REQUESTED BUT NOT INFORMED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THE CALCULATION RESULTS FROM ONE PATIENT TESTED FOR HBA1C (TINA-QUANT HBALC GEN. 3) ASSAY ON A COBAS 6000 C 501 MODULE. THE INITIAL HBA1C MEASUREMENT WAS 51.90 MMOL/MOL. THE RESULT CALCULATED BY COBAS 6000 AND TRANSFERRED TO THE LIS WAS 7.6%. THE RESULT CALCULATED MANUALLY WITH THE % DCCT/NGSP FORMULA (%HBA1C = (HBA1C/HB) + 91,5 +2,15) WAS 6.9%. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN.