CMV IGG ELECSYS E2G
Received Aug 11, 2023 · Event occurred Jul 8, 2023
Report 1823260-2023-02534 · MDR key 17509627
Device
Generic name
Cytomegalovirus Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
09118551190
Lot number
65796701
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE LAST CALIBRATION PERFORMED ON 25-MAY-2023 HAD LOWER SIGNALS THAN EXPECTED. QUALITY CONTROLS WERE NOT PERFORMED ON THE DAYS OF MEASUREMENT. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARM WAS OBSERVED AT THE TIME OF MEASUREMENT. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CMV IGG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. IT WAS ASKED BUT IT IS UNKNOWN IF A QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2023 THE RESULT OF THE FIRST SAMPLE WAS 10.6 U/ML (REACTIVE). ON (B)(6) 2023 THE RESULT OF A SECOND SAMPLE, COLLECTED FROM THE SAME PATIENT WAS LESS THAN 0.150 U/ML, ACCOMPANIED BY A DATA FLAG (NON-REACTIVE). ON (B)(6) 2023 THE INITIAL SAMPLE WAS REPEATED WITH A RESULT OF LESS THAN 0.150 U/ML, ACCOMPANIED BY A DATA FLAG (NON-REACTIVE).
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER¿S COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.