LIPASE COLORIMETRIC ASSAY
Received Jun 18, 2026 · Event occurred May 28, 2026
Report 1823260-2026-02447 · MDR key 25550044
Device
Generic name
Lipase Test System
Manufacturer
Roche DiagnosticsModel number
08057982190Catalog number
08057982190
Lot number
ASKU
Product problems
- Non Reproducible Results
Patient
72 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS C 703 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6), A HARDWARE PERFORMANCE CHECK WAS PERFORMED. CALIBRATION AND QUALITY CONTROL DATA WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE HIGH LIPASE COLORIMETRIC ASSAY RESULT FROM THE COBAS C 703 ANALYTICAL UNIT. THE CUSTOMER SUSPECTED AN INTERFERENCE WITH THE PATIENT'S MEDICATION. THE INITIAL RESULT WAS 521 U/I. ON THE SAME DAY, THE PATIENT WAS REDRAWN AT THE HOSPITAL, AND THE RESULT FROM THE NEW SAMPLE WAS 40 U/I.