ALINITY I CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I CMV IGG. THE CUSTOMER SAID THAT A PREGNANT PATIENT (DATE OF LAST PERIOD: (B)(6) 2024) HAD CMV IGG AND IGM PRESENT, AND THE SAME SERUM WAS THEN TESTED FOR AVIDITY (VIDAS PLATFORM) WHICH GENERATED AN UNINTERPRETABLE RESULT, NO ANTIBODIES. IT WAS CLARIFIED THAT THE CUSTOMER DID NOT RUN CMV IGG ON THE VIDAS PLATFORM, ONLY THE AVIDITY. THE CUSTOMER CONFIRMED THAT THEY ARE NOT QUESTIONING THE ALINITY I CMV IGM RESULTS AND THAT THE CUSTOMER FEELS THAT THE ALINITY I CMV IGG IS FALSE POSITIVE. THE CUSTOMER PROVIDED THE LABORATORY DATA: REFERENCE (= 6.0 AU/ML IS REACTIVE). ON (B)(6) 2024, SAMPLE ID (B)(6) GENERATED CMV IGG RESULT OF 73.8. SAMPLE WAS REPEATED ON (B)(6) (ID: (B)(6)), WHICH GENERATED A RESULT OF 75.3. THE SAMPLE WAS MANUALLY RETESTED AND GENERATED A RESULT OF 69.2. OTHER LABORATORY DATA: ON (B)(6) 2024: CMV IGM WAS 1.83 & 1.90 (REACTIVE), HIV WAS 0.06 S/CO (NEG), TOXO IGG WAS 18.5 IU/ML (POS), TOXO IGM WAS 0.52 INDEX (GRZ), RUB-IGG WAS 39.1 (POS) CMV IGM WAS REPEATED AND GENERATED A RESULT OF 1.59. PER THE CUSTOMER THE DISCREPANT RESULT(S) WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION ON 29 APR 24. THE CUSTOMER REPORTED THAT ADDITIONAL TESTING GENERATED THE SAME RESULTS AS ON THE ALINITY (CMV-IGG=41 WHEREAS POS >15 // CMV-IGM=33 WHEREAS POS >23) AND AVIDITY STILL UNINTERPRETABLE. THE PATIENT HAD A NEW SAMPLE DRAWN ON (B)(6), AND THE SEROLOGICAL PROFILE WAS STABLE FOR CMV-IGG AND CMV-IGM. THE CUSTOMER REPORTED THAT THEY ARE NO LONGER QUESTIONING THE CMV-IGG RESULT AND CONSIDER THE ISSUE RESOLVED.

Additional Manufacturer Narrative

B5 UPDATED WITH ADDITIONAL INFORMATION. UPDATE: THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION ON 29 APR 24. THE CUSTOMER REPORTED THAT ADDITIONAL TESTING GENERATED THE SAME RESULTS AS ON THE ALINITY (CMV-IGG=41 WHEREAS POS >15 // CMV-IGM=33 WHEREAS POS >23) AND AVIDITY STILL UNINTERPRETABLE THE PATIENT HAD A NEW SAMPLE DRAWN ON (B)(6), AND THE SEROLOGICAL PROFILE WAS STABLE FOR CMV-IGG AND CMV-IGM. THE CUSTOMER REPORTED THAT THEY ARE NO LONGER QUESTIONING THE CMV-IGG RESULT AND CONSIDER THE ISSUE RESOLVED. BASED UPON THIS NEW INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT.

Additional Manufacturer Narrative

A1 PATIENT IDENTIFIER: COMPLETE ID'S ARE (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I CMV IGG. THE CUSTOMER SAID THAT A PREGNANT PATIENT (DATE OF LAST PERIOD: (B)(6) 2024) HAD CMV IGG AND IGM PRESENT, AND THE SAME SERUM WAS THEN TESTED FOR AVIDITY (VIDAS PLATFORM) WHICH GENERATED AN UNINTERPRETABLE RESULT, NO ANTIBODIES. IT WAS CLARIFIED THAT THE CUSTOMER DID NOT RUN CMV IGG ON THE VIDAS PLATFORM, ONLY THE AVIDITY. THE CUSTOMER CONFIRMED THAT THEY ARE NOT QUESTIONING THE ALINITY I CMV IGM RESULTS AND THAT THE CUSTOMER FEELS THAT THE ALINITY I CMV IGG IS FALSE POSITIVE. THE CUSTOMER PROVIDED THE LABORATORY DATA: REFERENCE (= 6.0 AU/ML IS REACTIVE). ON (B)(6) 2024, SAMPLE ID (B)(6) GENERATED CMV IGG RESULT OF 73.8. SAMPLE WAS REPEATED ON 10 APR (ID: (B)(6) ), WHICH GENERATED A RESULT OF 75.3. THE SAMPLE WAS MANUALLY RETESTED AND GENERATED A RESULT OF 69.2. OTHER LABORATORY DATA: ON (B)(6) 2024: CMV IGM WAS 1.83 & 1.90 (REACTIVE), HIV WAS 0.06 S/CO (NEG), TOXO IGG WAS 18.5 IU/ML (POS), TOXO IGM WAS 0.52 INDEX (GRZ), RUB-IGG WAS 39.1 (POS) CMV IGM WAS REPEATED AND GENERATED A RESULT OF 1.59. PER THE CUSTOMER THE DISCREPANT RESULT(S) WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.