KIT COBAS 58/68/8800 MPX 480T US
Received Oct 8, 2025 · Event occurred Sep 8, 2025
Report 2243471-2025-04101 · MDR key 23246761
Device
Generic name
Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatiti
Manufacturer
Roche Molecular Systems, Inc. - BranchburgCatalog number
09040854190
Lot number
M20085
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF DISCREPANT HBV RESULTS WHEN USING THE COBAS® MPX (480T) ON THE COBAS 8800 ANALYZER FOR A SINGLE PATIENT. ON (B)^) 2025, THE INITIAL SAMPLE GENERATED A REACTIVE RESULT FOR HBV (CT 34.13). THE SAME SAMPLE WAS REPEATED ON THE SAME DAY AND GENERATED A REACTIVE HBV RESULT (CT 32.03). ON (B)(6) 2025, THE SAME SAMPLE WAS REPEATED AND GENERATED A REACTIVE RESULT FOR HBV (CT 31.73). SEROLOGY TESTING FOR THE SAMPLE WAS NEGATIVE. ON (B)(6) 2025, A RECOLLECTED SAMPLE GENERATED A NON-REACTIVE RESULT FOR HBV. NO SEROLOGY WAS PERFORMED ON THE RECOLLECTED SAMPLE.
Additional Manufacturer Narrative
THE COBAS 8800 SERIAL NUMBER WAS (B)(6). THE INVESTIGATION INDICATED NO PRODUCT-RELATED ISSUES WERE IDENTIFIED. IT CAN BE CONCLUSIVELY STATED THAT THERE ARE NO ISSUES WITH THE COBAS® MPX LOT M20085 THAT WAS USED AND A SOFTWARE ANOMALY OR AN ISSUE WITH THE RESULT CALLING ALGORITHM CAN BE EXCLUDED AS THE CAUSE FOR THE DISCREPANT RESULTS AS WELL AS ANY HARDWARE RELATED ISSUES. THE ANALYSIS OF THE PROVIDED DATA IN THIS CASE FURTHER CONFIRMS THAT THE COBAS® MPX TEST CORRECTLY IDENTIFIED THE SAMPLE AS HBV REACTIVE. ADDITIONALLY, THE ANALYSIS RULES OUT THE ROCHE POSITIVE CONTROL AS A POTENTIAL SOURCE OF CONTAMINATION.