MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LIPASE COLORIMETRIC ASSAY; LIPASE TEST SYSTEM

Model Number	08057982190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 303 analytical unit serial number is (b)(6).The customer reported that qc measured with the reagent lot 907469 was too high.The qc measured with the reagent lot 920585 was within specifications.The customer implemented an extra wash step (ews) and used a new calibrator lot.The customer reported that these actions have improved the machine's performance.The investigation was unable to determine a direct root cause as an overall instrument performance analysis was not possible.
Event or Problem Description
There was an allegation of a questionable lipase colorimetric assay result from the cobas c 303 analytical unit for four patients.Patient 1's initial result was 81.3 u/l, and the repeat result was 43.3 u/l.Patient 2's initial result was 87.9 u/l, and the repeat result was 41.7 u/l.Patient 3's initial result was 89.8 u/l, and the repeat result was 48.5 u/l.Patient 4's initial result was 78.0 u/l, and the repeat result was 32.8 u/l.The initial results were questioned because the patients were healthy.The repeat results were performed with a new reagent lot on the same instrument.

• Brand Name: LIPASE COLORIMETRIC ASSAY
• Common Device Name: LIPASE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23478682
• Report Number: 1823260-2025-04508
• Device Sequence Number: 13344578
• Product Code: CHI
• UDI-Device Identifier: 07613336121399
• UDI-Public: 07613336121399
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 08057982190
• Device Catalogue Number: 08057982190
• Device Lot Number: 907469, 920585
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown