ELECSYS CMV IGG ASSAY
Received Nov 11, 2021 · Event occurred Oct 15, 2021
Report 1823260-2021-03328 · MDR key 12793606
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsModel number
NACatalog number
07027117190
Lot number
568054
Product problems
- High Test Results
- High Test Results
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS CMV IGG RESULT FOR ONE PATIENT SAMPLE WITH COBAS E 801 MODULE (B)(4). THE INITIAL RESULT WAS 1.20 U/ML (REACTIVE). THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE DOCTOR. ON (B)(6) 2021, THE SAMPLE WAS TESTED IN ANOTHER LABORATORY ON AN UNKNOWN ANALYZER WITH A RESULT OF NEGATIVE (NON-REACTIVE).
Additional Manufacturer Narrative
THE SAMPLE WAS REQUESTED FOR INVESTIGATION.
Additional Manufacturer Narrative
THE CUSTOMER'S CALIBRATION AND QC RESULTS WERE WITHIN SPECIFICATION. THE CUSTOMER'S SAMPLE PRE-ANALYTIC DETAILS WERE REQUESTED BUT NOT PROVIDED. THE RESULT OF THE CUSTOMER COULD BE CONFIRMED. FURTHER INVESTIGATION SUGGESTS THAT THE SAMPLE IS CONSISTENT WITH A FALSE POSITIVE IN THE ELECSYS CMV IGG ASSAY. BASED ON DATA PRESENTED IN PRODUCT LABELING, SINGLE FALSE POSITIVES CAN OCCUR. THE REAGENT PERFORMS WITHIN SPECIFICATION. A GENERAL PRODUCT PROBLEM WAS NOT FOUND.