LIPASE COLORIMETRIC ASSAY
Received Jul 1, 2026 · Event occurred Nov 11, 2025
Report 1823260-2026-02644 · MDR key 25679822
Device
Generic name
Lipase Test System
Manufacturer
Roche DiagnosticsModel number
08057982190Catalog number
08057982190
Lot number
953204
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE -AMYLASE EPS VER.2 AND LIPASE COLORIMETRIC ASSAY RESULTS FOR 2 PATIENTS ON A COBAS C 503 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE LIPASE COLORIMETRIC ASSAY. PLEASE REFER TO: MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE -AMYLASE EPS VER.2 ASSAY. SEE THE ATTACHMENT (B)(6) FOR THE RESULTS. PATIENT 1'S INITIAL RESULTS WERE QUESTIONED BECAUSE THEY WOULD SUGGEST ACUTE PANCREATITIS; THE PATIENT'S PROTEIN PROFILE WAS NORMAL, AND THE PATIENT'S CLINICAL PICTURE WAS OVERALL NORMAL. BOTH PATIENTS' RESULTS WERE QUESTIONED BECAUSE THEY ARE YOUNG (E.G., 49 YEARS OLD) AND UNDERGO ROUTINE HORMONAL CHECKS, AND THE ATTENDING PHYSICIANS DEEMED THE RESULTS INCONSISTENT WITH THE CLINICAL PICTURE OF THE PATIENTS.
Additional Manufacturer Narrative
THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE ALARM LOG REVEALS FREQUENT ABNORMAL CELL BLANK (TWICE) AND ABNORMAL ASPIRATION (S1) ALARMS. THE INVESTIGATION IS ONGOING.