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

Model Number	08057982190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned high results not corresponding to the clinical picture for 1 patient taking plavix and tested for lipase colorimetric assay (lipc) on a cobas c 303 analytical unit.The initial result after dilution was 552 u/l on the c303 analyzer.The repeat result with dilution was 572 u/l on the c303 analyzer.The patient was sent to the emergency room, where the lipase result from a new sample on an unspecified cobas system was 40 u/l.On (b)(6) 2025, the original sample was repeated on the c303 analyzer, and the results were 444 u/l and 583 u/l after dilution.The customer suspects an interference with plavix affecting the results from the c303 analyzer.
Additional Manufacturer Narrative
The c303 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
The low lipc result of 40 u/l was believed to be correct as the patient had no clinical symptoms (abdominal pain).
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2025 with no issues.Qc was acceptable.No relevant instrument alarms were identified.Based on the results received, a physiological interference can be excluded.Based on the patient's medications and reaction kinetics, medication interference can be excluded.The sample for the initial results was collected at the patient's home by a nurse.The sample may have been contaminated or improperly stored during the collection process or transportation to the laboratory for testing.No lipase results for any other patient samples were affected.Based on the information available, the investigation determined the event was consistent with preanalytical handling issues.A product issue was not found.

• 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: 22642044
• Report Number: 1823260-2025-02317
• Device Sequence Number: 18313268
• 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,Followup
• Report Date (Section B): 11/10/2025

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: 04/30/2026
• Device Model Number: 08057982190
• Device Catalogue Number: 08057982190
• Device Lot Number: 87504401
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 10/26/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/04/2025; 11/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADENURIC; APROVEL; IRBESARTAN; PLAVIX; XYZALL
• Patient Sex: Male