MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATINE KINASE; CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM

Catalog Number	05168546190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ck creatine kinase results for 1 patient sample on a cobas 8000 c702 module.On (b)(6) 2024, the initial ck result was 8238 u/l.The sample was repeated with an increased dilution and the result was 3958 u/l.The sample was repeated again and the result was 10250 u/l.On (b)(6) 2024, the sample was repeated a third time and the result was 8256 u/l.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer declined further investigation and did not provide any additional information.No product problem could be identified.The root cause of the event could not be determined.

• Brand Name: CREATINE KINASE
• Common Device Name: CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19345754
• Report Number: 1823260-2024-01495
• Device Sequence Number: 2685274
• Product Code: JHS
• UDI-Device Identifier: 04015630924974
• UDI-Public: 04015630924974
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K160570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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: 05168546190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/17/2024
• 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