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

Model Number	08057982190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable lipase colorimetric assay results for 1 patient sample on a cobas c 503 analytical unit.The analyzer was being serviced by a field service engineer at the time when the initial result was produced which prompted the customer to repeat the sample.The initial result was 13.5 u/l.The sample was repeated on another c503 analyzer and the result was 42.0 u/l.The repeat result was deemed correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on 21-sep-2025.It was determined that the customer was running patient samples on the analyzer while active service and troubleshooting was taking place.The root cause of the event was found to be consistent with user error.No product problem was identified.

• 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: 23606855
• Report Number: 1823260-2025-04753
• Device Sequence Number: 13241133
• Product Code: CHI
• UDI-Device Identifier: 07613336121399
• UDI-Public: 07613336121399
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 899254
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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