MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LIPASE COLORIMETRIC ASSAY; LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Catalog Number	03029590322
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: LIPASE COLORIMETRIC ASSAY
• Common Device Name: LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
• 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: 23498210
• Report Number: 1823260-2025-04544
• Device Sequence Number: 8973646
• Product Code: CHI
• UDI-Device Identifier: 04015630917570
• UDI-Public: 04015630917570
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K972250
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 03029590322
• Device Lot Number: 85789901
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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