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

Catalog Number	07190794190
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with ck creatine kinase on two cobas 6000 c (501) module analyzers.No incorrect results were reported outside of the laboratory.The customer suspected the sample contains an interfering factor against a component of the ck assay.The sample was tested on the first c 501 analyzer, resulting in a value of < 6 u/l with a data flag.The sample was tested twice on the second c 501 analyzer, each time resulting in a value of < 6 u/l with a data flag.A serial number of (b)(4) was provided for one of the two c 501 analyzers.It is not known if this was the first analyzer or the second analyzer used for testing.The serial number of the other c 501 analyzer was requested, but not provided.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15959879
• Report Number: 1823260-2022-03969
• Device Sequence Number: 4951997
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/03/2023

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: 06/30/2023
• Device Catalogue Number: 07190794190
• Device Lot Number: 664843
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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