ELECSYS CMV IGG
Received Mar 31, 2025 · Event occurred Mar 4, 2025
Report 1823260-2025-00940 · MDR key 21729832
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
09118551190
Lot number
80587601
Product problems
- Low Test Results
- Low Test Results
Patient
25 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CMV IGG RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER REPORTED REPETITIVE NEGATIVE ELECSYS CMV IGG RESULTS, WITH AN INITIAL RESULT OF 0.478 U/ML ON (B)(6) 2025 AND REPEAT RESULTS OF 0.502 U/ML AND 0.603 U/ML ON (B)(6) 2025. THEY RECEIVED A POSITIVE CMV AVIDITY RESULT FROM AN EXTERNAL LAB OF 0.68 U/ML ON (B)(6) 2025. A RESULT FOR CMV IGM WAS PROVIDED AS 8.45 COI.
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT THERE WAS NO PRODUCT PROBLEM.