ELECSYS CMV IGM
Received Sep 14, 2023 · Event occurred Aug 4, 2023
Report 1823260-2023-02977 · MDR key 17744102
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsCatalog number
07027133190
Lot number
706335
Product problems
- False Negative Result
- False Negative Result
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 IGM (CMV IGM) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE REPORTER CONFIRMED THE INITIAL RESULT USING A MINI VIDAS ANALYZER. THE INITIAL RESULT FROM THE ANALYZER WAS 0.35 CUT-OFF INDEX COI (NEGATIVE). THE REPEAT RESULT FROM THE MINI VIDAS ANALYZER WAS 1.28 (POSITIVE). THE PATIENT IS SUSPECTED TO HAVE CYTOMEGALOVIRUS (CMV) INFECTION.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E 801 ANALYTICAL UNIT IS (B)(4). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. A STATEMENT WAS PROVIDED THAT THE QC AND CALIBRATION WERE CONSIDERED CORRECT. PRODUCT LABELING STATES "IN SOME INDIVIDUALS NON-REACTIVE RESULTS MAY OCCUR IN THE LATE PHASE OF ACUTE INFECTION BY THE ELECSYS CMV IGM ASSAY. AS WITH ANY IN VITRO DIAGNOSTIC TEST, FALSE RESULTS MAY OCCUR." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.