ELECSYS CMV IGG
Received Apr 10, 2025 · Event occurred Oct 25, 2024
Report 1823260-2025-01099 · MDR key 21813924
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
09118551190
Lot number
79229801
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 SERIAL NUMBER OF THE COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CMV IGG ASSAY RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS E 801 ANALYTICAL UNIT. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.
Additional Manufacturer Narrative
THE INVESTIGATION REVIEWED THE QC DATA; THE RESULTS WERE WITHIN THE SPECIFIED RANGES. THE CUSTOMER STATED THAT THE CMV WESTERN BLOT RESULTS FOR THE ON (B)(6) 2024 PATIENT SAMPLES WERE "NEGATIVE WITHOUT ANY DETECTED BAND". THE INVESTIGATION DETERMINED THAT THE PATIENT'S RESULTS ARE CONSISTENT WITH EARLY CMV INFECTION (SEROCONVERSION). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.