MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM CREATINE KINASE MB (CKMB)

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of elevated atellica im creatine kinase mb (ckmb, lot 279) results which were discordant relative to repeat testing using lot 281.Initial elevated results were obtained for four (4) patient samples.The initial results were not reported to the physician(s).The same samples were then retested using an alternate reagent lot 281 and obtained lower results.The lower results matched the clinical pictures of the patients, considered correct and reported to the physician(s).There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of elevated atellica im creatine kinase mb (ckmb, lot 279) results which were discordant relative to repeat testing using lot 281.Quality control (qc) recovered within laboratory established ranges.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is evaluating the event.
Additional Manufacturer Narrative
Mdr 1219913-2024-00490 was initially filed on 05-dec-2024.Additional information (12-feb-2025): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states reported observation of elevated atellica im creatine kinase mb (ckmb) results which were discordant relative to repeat testing.Siemens evaluated the instrument data and the information provided by the customer.Siemens compared qc and patient sample results between the affected reagent lot 279 and the new lot 281.The results remained within the laboratory's accepted ranges and deviations.Based on the available information, a specific cause for the discordant results was unable to be determined.The issue was resolved by routine troubleshooting; a product problem was not identified.The customer is operational and no further actions are required.Note: in section h6, codes for investigation findings and investigation conclusions were updated.

• Brand Name: ATELLICA IM CREATINE KINASE MB (CKMB)
• Common Device Name: ATELLICA IM CREATINE KINASE MB (CKMB)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 20852785
• Report Number: 1219913-2024-00490
• Device Sequence Number: 20858075
• Product Code: JHS
• UDI-Device Identifier: 00630414598581
• UDI-Public: (01)00630414598581(10)69105279(17)250326
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962126
• 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,Followup
• Report Date (Section B): 03/10/2025

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: 03/26/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995531
• Device Lot Number: 69105279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown