STAR COMPL. WITH ACCESSORIES
Received Mar 20, 2026 · Event occurred Dec 9, 2025
Report 2243471-2026-01016 · MDR key 24650366
Device
Generic name
Station, Pipetting And Diluting, For Clinical Use
Manufacturer
Roche Molecular Systems, Inc. - BranchburgCatalog number
04640535001
Product problems
- Computer Software Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF SAMPLE ID MISMATCHES WHEN USING THE HAMILTON STAR COMPL. WITH ACCESSORIES POOLER. THE CUSTOMER REPORTED THAT TWO OF THEIR POOLERS INTERMITTENTLY FAIL TO RECOGNIZE THE CORRECT NUMBER OF SAMPLE POOLS, LEADING TO SAMPLE IDS BEING ASSIGNED TO THE WRONG TUBES. ON POOLER SERIAL NUMBER (B)(6), INITIALLY, A BATCH OF (B)(4) SAMPLES WAS LOADED, EXPECTED TO FORM 32 POOLS, BUT ONLY (B)(4) POOLS WERE RECOGNIZED. A SIMILAR ISSUE OCCURRED LATER, WHERE ONLY (B)(4) SAMPLES WERE RECOGNIZED INSTEAD OF 24. ADDITIONALLY, THE SECOND POOLER, SERIAL NUMBER (B)(6), EXHIBITED THE SAME BEHAVIOR. THE CUSTOMER REBOOTED THE POOLER AND PC, WHICH RESOLVED THE ISSUE TEMPORARILY. NO ERRONEOUS RESULTS WERE REPORTED AS THE SAMPLE MISMATCHES WERE RESOLVED AFTER RELOADING.
Additional Manufacturer Narrative
THE HAMILTON STAR COMPL. WITH ACCESSORIES IS AN INSTRUMENT USED WITH THE COBAS® 6800/8800 SYSTEMS FOR AUTOMATED PIPETTING AND POOLING OF ALIQUOTS OF MULTIPLE PRIMARY SAMPLES INTO ONE POOLED SAMPLE. INVESTIGATION IS ONGOING.