MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LIPC; 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	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable lipc results for 2 patient samples on a cobas c 311 analyzer.Sample 1: the initial result was 734.0 u/l.The sample was tested at another laboratory, using a different platform (reflectance method) and the result was 2,000 u/l.On (b)(6) 2025 the sample was repeated on the cobas module and the results were 329 u/l with a data flag, 431.0 u/l, and 422 u/l.On (b)(6) 2025 the sample was repeated on the cobas module and the result was 469.7 u/l.Sample 2: on (b)(6) 2025 the initial result was 342 u/l with a data flag.The sample was repeated with a manual dilution of 1:50 and the result was 600 u/l.The sample was tested at another laboratory and the result was 2,226 u/l.On (b)(6) 2025 the sample was tested and the results were 477 u/l and 582 u/l (with a 1:20 dilution).The samples were repeated due to the results not matching the patients' clinical history.
Additional Manufacturer Narrative
The qc was within specification.Based on the data and information, a general reagent-specific issue is unlikely.The field service representative performed a correlation study of the results with a cobas c501 module and found the results were reproduced correctly.The investigation did not identify a product problem.

• Brand Name: LIPC
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21344717
• Report Number: 1823260-2025-00382
• Device Sequence Number: 13012599
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 05/31/2025
• Device Catalogue Number: 03029590322
• Device Lot Number: 80650901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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