ELECSYS CMV IGG ASSAY
Received Aug 23, 2021 · Event occurred Jul 28, 2021
Report 1823260-2021-02444 · MDR key 12355709
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsModel number
NACatalog number
07027117190
Lot number
52258301
Product problems
- Low Test Results
- Low Test Results
Patient
21 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CALIBRATION AND QC RESULTS WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE CMV IGG ELECSYS RESULT FROM COBAS E 801 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS <0.25 UI/ML(NEGATIVE). THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED BY DIASORIN METHOD WITH A RESULT OF 28.9 UI/ML (POSITIVE). ON (B)(6) 2021, THE SAME SAMPLE WAS RETESTED ON ANOTHER COBAS ANALYZER AND THE RESULT WAS <0.25 (NEGATIVE). THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT ISSUE CAN BE EXCLUDED.