COBAS C 503 ANALYTICAL UNIT
Received Oct 6, 2025 · Event occurred Sep 15, 2025
Report 1823260-2025-04065 · MDR key 23220464
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsCatalog number
08463662001
Lot number
855124
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE LDL-CHOLESTEROL GEN.3 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 17.8 MG/DL. ON (B)(6) 2025, THE REPEAT RESULT WAS 169 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER FOUND THAT THE PROTECTIVE PLATE AND THE CAPS OF THE ULTRASONIC MIXERS WERE COVERED IN SERUM. THE PROBES FOR SAMPLE AND REAGENT PIPETTING WERE ADJUSTED HORIZONTALLY AND VERTICALLY. THE TUBE AND VACUUM CONTAINER FOR DILUTED WASTE WERE CLEANED, AS WELL AS THE ADJACENT TUBING FROM THE CUVETTE WASH STATION. A HARDWARE CHECK WAS EXECUTED, AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE EVENT WAS CONSISTENT WITH AN INSTRUMENT ISSUE OR A PRE-ANALYTICAL HANDLING ISSUE AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY.