MAUDE Adverse Event Report: Roche Diagnostics Creatine Kinase; Cpk Or Isoenzymes

Catalog Number	07190794190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable creatine kinase results for 12 patient samples on a cobas 4000 c311 stand alone system.As a representative example, three patient results are provided.Patient 1's initial result was 680 u/l.The repeat result from a different c311 was 66 u/l.Patient 2's initial result was 1008 u/l.The repeat result from a different c311 was 97 u/l.Patient 3's initial result was 1890 u/l.The repeat result from a different c311 was 197 u/l.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The cobas 4000 c311 stand alone system serial number is (b)(6).The calibration failed 3 times with std.E flags and only passed when using a new reagent pack.The std.E flag indicates issues with calibrator assignment or preparation; calibrations with the new reagent cassette were overall inconspicuous but had slightly higher values for both standards.As calibration was successful and correct results were acquired using the same reagent pack on the new device, a reagent/reagent pack-specific issue can be excluded as the root cause.The alarm trace does not show any relevant alarms for the time around the measurements.The investigation is ongoing.

• Brand Name: Creatine Kinase
• Common Device Name: Cpk Or Isoenzymes
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50856428
• Report Number: 1823260-2026-03884
• Device Sequence Number: 9553498
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (Y/N): N
• Initial Reporter Country: CE
• 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): 09/22/2026

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: 956969
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• 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