ELECSYS CMV IGG
Received Nov 3, 2025 · Event occurred Oct 8, 2025
Report 1823260-2025-04461 · MDR key 23453463
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsModel number
CMV IGGCatalog number
09118551190
Lot number
86361301
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SAMPLE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. ADDITIONAL INFORMATION AND RELEVANT DATA WERE REQUESTED, BUT NOT PROVIDED BY THE CUSTOMER. A GENERAL PRODUCT PROBLEM WAS NOT FOUND. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
IN THE INITIAL MEDWATCH, THE STATEMENT IN B5 DESCRIBE EVENT OR PROBLEM SHOULD HAVE BEEN: "REPEAT RESULT: 125.0 U/ML (INTERPRETED AS POSITIVE)." INSTEAD OF: "REPEAT RESULT: 125.0 U/ML (TESTED WITH ABBOTT CMV IGG AND INTERPRETED AS POSITIVE)." THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025, AND IT WAS WITHIN THE EXPECTED RANGES. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CMV IGG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: 0.0 U/ML (INTERPRETED AS NEGATIVE). REPEAT RESULT: 125.0 U/ML (TESTED WITH ABBOTT CMV IGG AND INTERPRETED AS POSITIVE).