CMV IGG ELECSYS E2G

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE POSITIVE RESULTS FOR 16 PATIENT SAMPLES TESTED WITH THE ELECSYS CMV IGG ASSAY ON A COBAS 8000 E 801 MODULE. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY A DOCTOR. 15 OF THE SAMPLES WERE REPEATED WITH THE ABBOTT CMV IGG METHOD AND THESE RESULTS WERE NEGATIVE. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

Additional Manufacturer Narrative

IN ADDITION TO REAGENT LOT 61916801, REAGENT LOTS 596229, 634409, AND 657967 WERE ALSO USED IN THE MEASUREMENT OF THE AFFECTED PATIENT SAMPLES. IT IS NOT KNOWN WHICH LOT WAS USED FOR EACH SAMPLE MEASUREMENT. THE REAGENT EXPIRATION DATES WERE NOT PROVIDED. FOR THE SAMPLE CLINICAL INFORMATION, THESE ARE DEFINITIONS OF SOME ACRONYMS: MMA = "TIRED, DULL, AND KNOCKED OFF" (V.A.) ALL = ACUTE LYMPHATIC LEUKEMIA CABG = CORONARY ARTERY BYPASS GRAFT 20 PATIENT SAMPLES WERE PROVIDED FOR INVESTIGATION AND THE CMV IGG RESULTS OBTAINED BY THE CUSTOMER COULD BE REPRODUCED.

Additional Manufacturer Narrative

THE QUESTIONABLE RESULTS FROM THE FOUR NEW SAMPLES (SAMPLE IDS (B)(6)) WERE REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

DATA WAS PROVIDED FOR SEVEN ADDITIONAL SAMPLES THAT HAD QUESTIONABLE POSITIVE CMV IGG RESULTS WHEN TESTED WITH THE ROCHE ASSAY. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE ATTACHMENT INCLUDES INFORMATION THAT HAS BEEN REPORTED PREVIOUSLY. ALL INFORMATION HIGHLIGHTED IN YELLOW IS NEW, UPDATED INFORMATION.

Additional Manufacturer Narrative

DATA WAS PROVIDED FOR FOUR ADDITIONAL SAMPLES THAT HAD QUESTIONABLE POSITIVE CMV IGG RESULTS WHEN TESTED WITH THE ROCHE ASSAY. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA.

Additional Manufacturer Narrative

THE 20 SAMPLES WERE INVESTIGATED AND THESE WERE THE FINDINGS: THE RESULTS OF THE CUSTOMER COULD BE CONFIRMED AND A HIGH AVIDITY IN LOW REACTIVE IGG SAMPLES WAS DETECTED. NO DIFFERENCES BETWEEN BIOTIN AND NON-BIOTIN UPDATED ASSAY VERSIONS AND NO INTERFERENCE BASED ON THE USED COMPONENTS WERE IDENTIFIED. FOR THE FOLLOWING SAMPLES, PROMINENT REACTIVITY TO P150 COULD BE CLARIFIED: (B)(6). FOR THE FOLLOWING SAMPLES, ONLY A SLIGHT CMV REACTIVITY WAS DETECTED IN RECOMLINE BLOTS, HENCE THE STATUS OF THESE PATIENTS IS NOT COMPLETELY CLEAR: (B)(6). FOR THE FOLLOWING SAMPLES, THERE WAS NO CONCORDANT DIAGNOSTIC PICTURE: (B)(6). GIVEN THE UNCLEAR SEROLOGIC PATTERNS OF SOME PATIENTS, THESE PATIENTS MAY BE CONSIDERED SERONEGATIVE FOR CMV AND THEREFORE, APPLYING APPROPRIATE MEASURES OF PROTECTION AGAINST CMV INFECTION DURING PREGNANCY. FOLLOW-UP SAMPLES FROM THESE PATIENTS COULD HELP TO CLARIFY THE UNCLEAR STATUS OF THE SAMPLES.