LIPASE COLORIMETRIC ASSAY
Received Nov 7, 2025 · Event occurred Oct 14, 2025
Report 1823260-2025-04544 · MDR key 23498210
Device
Generic name
Lipase-esterase, Enzymatic, Photometric, Lipase
Manufacturer
Roche DiagnosticsCatalog number
03029590322
Lot number
85789901
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE LIPASE COLORIMETRIC ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 248.6 U/L. THE REPEAT RESULT WAS 31.4 U/L. THE INITIAL RESULT WAS DEEMED ELEVATED AND NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WITHIN THE NORMAL RANGE WAS REPORTED BASED ON THE PATIENT'S CLINICAL HISTORY.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE COBAS 6000 C501 MODULE IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE CALIBRATION REPORT PROVIDED BY THE CUSTOMER SHOWS A LOT OF FLAGS. THE QC RECOVERY WAS WITHIN SPECIFICATIONS, WITH THE EXCEPTION OF TWO TIMES WHEN IT WAS OUT OF SPECIFICATION. NO PRODUCT PROBLEM IDENTIFIED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE, AS ADDITIONAL INFORMATION WAS NOT PROVIDED.