ELECSYS CMV IGG
Received Apr 18, 2025 · Event occurred Mar 28, 2025
Report 1823260-2025-01185 · MDR key 21866320
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
09118551190
Lot number
82318601
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 CUSTOMER COMPLAINED OF A QUESTIONABLE NEGATIVE CMV IGG RESULT FOR AN ADDITIONAL PATIENT SAMPLE (PATIENT 2): ON (B)(6) 2025, THE RESULT FROM THE E801 ANALYZER WAS <0.15 U/ML (NEGATIVE). THE RESULT FROM THE VIDAS METHOD WAS 8 AU/ML (POSITIVE). SECTIONS B6 AND B7 WERE UPDATED. FOR PATIENT 1, THE INITIAL REPORT STATED: "THE RESULT FROM THE E801 ANALYZER WAS <15 U/ML (NEGATIVE)." THIS SHOULD SAY: "THE RESULT FROM THE E801 ANALYZER WAS < 0.15 U/ML (NEGATIVE)." SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION.
Additional Manufacturer Narrative
CALIBRATION AND QC WERE ACCEPTABLE. SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION, BUT WAS NOT PROVIDED. AS NO SAMPLE MATERIAL WAS AVAILABLE, 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 A NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS E 801 ANALYTICAL UNIT. THE RESULT FROM THE E801 ANALYZER WAS < 15 U/ML (NEGATIVE). THE RESULT FROM A COMPETITOR METHOD WAS 38 (POSITIVE). THE UNIT OF MEASURE WAS NOT PROVIDED.
Additional Manufacturer Narrative
THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE COMPETITOR METHOD WAS VIDAS.