ELECSYS CMV IGM
Received Mar 20, 2025 · Event occurred Feb 27, 2025
Report 1823260-2025-00799 · MDR key 21652131
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Manufacturer
Roche DiagnosticsCatalog number
07027133190
Lot number
ASKU
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO FOLLOW-UP SAMPLES WERE RECEIVED FOR THE SPECIFIC PATIENTS MENTIONED IN THE INITIAL REPORT. THE CUSTOMER RECEIVED "SOME" FOLLOW-UP SAMPLES FROM PATIENTS WITH QUESTIONABLE "NEGATIVE" ELECSYS CMV IGM RESULTS. THE SAMPLES WERE TESTED BY THE ARCHITECT METHOD WITH "POSITIVE" RESULTS. THE FOLLOW-UP SAMPLES WERE "NEGATIVE" BY THE ARCHITECT METHOD; THEREFORE, THE NEGATIVE RESULTS WERE BELIEVED TO BE CORRECT. AS NO SAMPLE MATERIAL WAS AVAILABLE FOR INVESTIGATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED NEGATIVE RESULTS FOR 11 PATIENT SAMPLES TESTED FOR ELECSYS CMV IGM (CMV IGM) ON A COBAS E 402 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THE RESULTS FOR ALL 11 PATIENT SAMPLES WERE "NEGATIVE" ON THE E402 ANALYZER. THE RESULTS FOR THE 11 PATIENT SAMPLES WERE EITHER "POSITIVE" OR INDETERMINATE BY THE COMPETITOR METHOD. NO ACTUAL RESULTS HAVE BEEN PROVIDED.
Additional Manufacturer Narrative
THE E402 ANALYZER SERIAL NUMBER WAS (B)(6). THE COMPETITOR METHOD WAS ABBOTT ARCHITECT.