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

Model Number	08057982190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable lipase colorimetric assay results from the cobas c 503 analytical unit.The customer alleged there was a potential interference.The results were 33.6 u/l and 34.6 u/l > accompanied by data flags.A manual 1:20 dilution 1was performed and the result was 27.9 u/l ( x 20 = 558 u/l).The sample was retested undiluted on another analyzer, and the result was 35.7 u/l.A new manual 1:10 dilution was performed, and the results were 40.9 u/l with a data flag (x 10= 409 u/l) and 41.7 u/l (x 10=417 u/l).On (b)(6) 2025, a new sample was collected from the patient, and the results were 34.1 u/l and 34.5 u/l.A new 1:10 manual dilution was performed, and the results were 40.5 u/l with a data flag ( x 10=405), 40.8 u/l ( x 10=408), and 42.6 u/l (x 10=426).
Additional Manufacturer Narrative
The investigation determined that the event was consistent with a gammopathy.Per product labeling for the assay: in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.There was no evidence of a device malfunction.

• 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: 23830132
• Report Number: 1823260-2025-05180
• Device Sequence Number: 18381159
• Product Code: CHI
• UDI-Device Identifier: 07613336121399
• UDI-Public: 07613336121399
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/17/2026

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: 883398
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/17/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENOSUMAB; LEFLUNOMIDE
• Patient Sex: Unknown