MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATINE KINASE; CPK OR ISOENZYMES

Catalog Number	07190794190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with creatine kinase (ck) assay on a cobas 6000 c501 module.Initial result: 78 u/l.The physician questioned the initial result as it did not match the patient's previous result of 132,220 u/l.The physician expected the initial result to be >100,000 u/l.The sample was then repeated at multiple dilutions (both with auto-dilution by the instrument and manual dilution), and the repeat results were >100,000 u/l.One of the repeat results was 163,985 u/l (accompanied by a data flag).The final repeat result was 181,100 u/l.
Additional Manufacturer Narrative
The ck reagent expiration date was not provided.The c501 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The provided photo showed many white spots on the wall of the sample tube.The centrifugal force and clotting time used by the customer did not meet the manufacturer¿s recommended requirements.The investigation did not identify a product problem.The cause of the event was consistent with a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.

• Brand Name: CREATINE KINASE
• Common Device Name: CPK OR ISOENZYMES
• 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: 22521887
• Report Number: 1823260-2025-02175
• Device Sequence Number: 12901691
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K160570
• 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): 08/14/2025

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 Catalogue Number: 07190794190
• Device Lot Number: ASKU
• 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: 06/21/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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