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

Model Number	08057982190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with lipase colorimetric assay on a cobas c 503 analytical unit, not consistent with the patient's condition.Initial result: 615 u/l.The physician questioned the initial result as it was high and was not consistent with the patient's condition.The physician requested a new sample to be drawn and tested on the same cobas c 503 analytical unit, resulting in a value of 86 u/l.The original sample was then repeated on a different cobas analytical unit at the customer's site, and the value of 615 u/l was confirmed.The specific result received was not provided.
Additional Manufacturer Narrative
The lipase reagent expiration date was not provided.The cobas c 503 analytical unit serial number was: (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Based on the consistent results across two different cobas c instruments, the cause of the event was not an instrument or reagent issue.The investigation did not identify a product problem.The cause of the event was consistent with a physiological or a preanalytical issue at the customer site.Preanalytics are within the customer's responsibility.

• 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: 23696493
• Report Number: 1823260-2025-04913
• Device Sequence Number: 10375876
• Product Code: CHI
• UDI-Device Identifier: 07613336121399
• UDI-Public: 07613336121399
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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