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

Catalog Number	07190794190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).Sample 1 was hemolysed.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ckmbl creatine kinase-mb results for 1 patient on a cobas 6000 c501 module.Sample 1: the initial result was 8712 u/l.This result was reported outside the laboratory.The sample was repeated with a 1:10 dilution on another module and the result was 877 u/l.The sample was repeated on another module and the results were: 7249 u/l with a data flag that invalidated the result, 7348 u/l with a data flag that invalidated the result, 7124 u/l with a data flag that invalidated the result, 7108 u/l with a data flag that invalidated the result, 8280 u/l with a data flag that invalidated the result, and 8374 u/l with a data flag that invalidated the result.Sample 2: a new sample was tested on another module and the result was 54 u/l the sample was repeated with a 1:10 dilution on another module and the result was 7 with a data flag that invalidated the result.Sample 3: a new sample was tested on another module and the result was 61 u/l.The results of "55-60 u/l" were considered to be correct.
Additional Manufacturer Narrative
The calibration was acceptable.The qc data showed a very slight downward trend, but results were within specification.The investigation did not identify a product problem.The investigation determined the issue was consistent with a pre-analytical handling issue.

• Brand Name: CKMBL CREATINE KINASE-MB
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20645570
• Report Number: 1823260-2024-03251
• Device Sequence Number: 7464076
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K951595
• 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): 12/17/2024

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 07190794190
• Device Lot Number: 79940601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STATINS FOR CHOLESTEROL
• Patient Sex: Unknown