ELECSYS CMV IGM
Received Oct 15, 2025 · Event occurred Sep 13, 2025
Report 1823260-2025-04166 · MDR key 23278151
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsCatalog number
07027133190
Lot number
868384
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION B7 WAS UPDATED. ONE SAMPLE WAS RECEIVED FOR INVESTIGATION ON 06-NOV-2025. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE CALIBRATION AND QC RESULTS WERE WITHIN THE EXPECTED RANGES. THE SAMPLE WAS RECEIVED FOR INVESTIGATION ON 06-NOV-2025, AND WAS TESTED USING THE ELECSYS ASSAYS AND COMPETITOR ASSAYS: ELECSYS CMV IGM ASSAY: 0.307 COI (NON-REACTIVE). ELECSYS CMV IGG ASSAY: 0.701 U/ML (BORDERLINE). PLATELIA CMV IGM ASSAY: 0.89 COI (BORDERLINE). MIKROGEN RECOMLINE CMV IGM ASSAY: NON-REACTIVE MIKROGEN RECOMLINE CMV IGG ASSAY: NON-REACTIVE. THE INVESTIGATION CONFIRMED THE CUSTOMER'S ELECSYS CMV IGM RESULTS. THE ELECSYS CMV IGM ASSAY RESULT WAS SUPPORTED BY THE RESULTS OF COMPETITOR ASSAYS AND WAS CONSIDERED CORRECT. THE INVESTIGATION DETERMINED THAT THE PATIENT MAY HAVE HAD A VERY EARLY CYTOMEGALOVIRUS (CMV) INFECTION, OR THE OBSERVED REACTIVE CMV IGM RESULTS WERE CAUSED BY CROSS-REACTIVITY, POSSIBLY DUE TO EPSTEIN-BARR VIRUS (EBV) INFECTION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CMV IGM ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: 0.337 COI AND INTERPRETED AS NON-REACTIVE. ON (B)(6) 2025: THE SAMPLE WAS TESTED, AND THE RESULT WAS 0.326 COI AND INTERPRETED AS NEGATIVE. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY USING THE CHEMILUMINESCENCE METHOD AND REPEATED. THE 1ST REPEAT RESULT WAS 56.1 AND INTERPRETED AS POSITIVE. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THIS RESULT WAS REPORTED. THE SAMPLE WAS THEN REPEATED USING THE ENZYME-LINKED FLUORESCENCE ASSAY (ELFA) METHOD ON A DIASORIN LIAISON INSTRUMENT, AND THE 2ND REPEAT RESULT WAS POSITIVE. ON (B)(6) 2025: THE SAMPLE WAS TESTED AFTER PERFORMING QC, AND THE RESULT WAS 0.316 COI AND INTERPRETED AS NON-REACTIVE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.