MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATINE KINASE; CPK, DIFFERENTIAL RATE KINETIC METHOD

Catalog Number	08057460190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial analyzer serial number is (b)(6).The second analyzer serial number (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable creatine kinase results for 3 patient samples on a cobas c 503 analytical unit.The customer repeated previous patient samples on a new reagent lot as they were having issues with qc recovering high.Sample 1 had an initial result of 79.0 u/l.The sample was repeated on another analyzer and the result was 67.5 u/l.On (b)(6) 2026, the sample was repeated on the initial analyzer with a new reagent lot and the result was 59.5 u/l.Sample 2 had an initial result of 62.0 u/l.The sample was repeated on another analyzer and the result was 48.0 u/l.On (b)(6) 2026, the sample was repeated on the initial analyzer with a new reagent lot and the result was 47.6 u/l.Sample 3 had an initial result of 15075.0 u/l.On (b)(6) 2026, the sample was repeated with a new reagent lot and the result was 9683 u/l.The repeat results from the new reagent lot were deemed correct.Clarification on whether the initial results were produced on (b)(6)2026 was not provided.
Additional Manufacturer Narrative
The calibration recovery data provided was within specification.The customer's qc recovery showed imprecision trending high.Based on the provided pre-analytical information, the customer's centrifugation time may be shorter than recommended and the speed may be faster than recommended.The field service engineer (fse) found that the pipette that customer has used to prepare controls was out of specification and caused the qc material to fail when performed.Once a new pipette was used to prepare fresh materials, the qc was successful.The investigation did not identify a product problem.The root cause of the event was found to be consistent with a handling problem at the customer site.

• Brand Name: CREATINE KINASE
• Common Device Name: CPK, DIFFERENTIAL RATE KINETIC METHOD
• 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: 24851932
• Report Number: 1823260-2026-01372
• Device Sequence Number: 8926667
• Product Code: JHS
• UDI-Device Identifier: 07613336121122
• UDI-Public: 07613336121122
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 08057460190
• Device Lot Number: 91855901
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 06/10/2026
• 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 Age: 82 YR
• Patient Sex: Female