LIPASE COLORIMETRIC ASSAY
Received Feb 12, 2026 · Event occurred Jan 21, 2026
Report 1823260-2026-00492 · MDR key 24320634
Device
Generic name
Lipase Test System
Manufacturer
Roche DiagnosticsModel number
08057982190Catalog number
08057982190
Lot number
926472
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO SB ANALYZER. THE INITIAL RESULT WAS 396 U/L. THE PATIENT HAD A NEW SAMPLE COLLECTED AT ANOTHER HOSPITAL AND THE RESULT WAS 67 U/L. THE PATIENT ALSO HAD A RESULT OF 400 U/L FROM ANOTHER COBAS PRO MODULE IN ANOTHER LABORATORY. THE SAME REAGENT LOT USED FOR THE INITIAL SAMPLE WAS UTILIZED. CLARIFICATION ON WHETHER THIS WAS A REPEAT RESULT FROM THE FIRST OR SECOND SAMPLE WAS NOT PROVIDED.
Additional Manufacturer Narrative
THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE PATIENT SAMPLES WERE RECEIVED FOR INVESTIGATION, THE CUSTOMER'S RESULTS WERE ABLE TO BE CONFIRMED. BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.