LIPASE COLORIMETRIC ASSAY
Received Nov 20, 2025 · Event occurred Oct 31, 2025
Report 1823260-2025-04753 · MDR key 23606855
Device
Generic name
Lipase Test System
Manufacturer
Roche DiagnosticsModel number
08057982190Catalog number
08057982190
Lot number
899254
Product problems
- Low Test Results
- Low Test Results
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 QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE ANALYZER WAS BEING SERVICED BY A FIELD SERVICE ENGINEER AT THE TIME WHEN THE INITIAL RESULT WAS PRODUCED WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE INITIAL RESULT WAS 13.5 U/L. THE SAMPLE WAS REPEATED ON ANOTHER C503 ANALYZER AND THE RESULT WAS 42.0 U/L. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
CALIBRATION WAS LAST PERFORMED ON 21-SEP-2025. IT WAS DETERMINED THAT THE CUSTOMER WAS RUNNING PATIENT SAMPLES ON THE ANALYZER WHILE ACTIVE SERVICE AND TROUBLESHOOTING WAS TAKING PLACE. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH USER ERROR. NO PRODUCT PROBLEM WAS IDENTIFIED.