MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® MASS CREATINE KINASE MB ISOENZYME (MMB) FLEX® REAGENT CARTRIDGE

Model Number	10444904
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated mass creatine kinase mb isoenzyme (mmb) patient sample result obtained on a dimension exl 200 system.Siemens is investigating the event.
Event or Problem Description
A discordant falsely elevated mass creatine kinase mb isoenzyme (mmb) patient sample result was obtained on a dimension exl 200 system.The falsely elevated patient result was not reported to the physician.The same sample was reprocessed on two alternate non-siemens systems.The results obtained were lower and considered correct.The result from one non-siemens system was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated mass creatine kinase mb isoenzyme (mmb) result.
Additional Manufacturer Narrative
Additional information (08-feb-2023): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer.No product non-conformance was identified with the dimension exl 200 system or mass creatine kinase mb isoenzyme (mmb) assay.The cause of the event was determined to be the presence of a patient specific heterophilic antibody interferent.This is not a product issue as the mass creatine kinase mb isoenzyme (mmb) instructions for use states that the "patient samples may contain heterophilic antibodies that could react with immunoassays to give falsely elevated or depressed results.Mass creatine kinase mb isoenzyme (mmb) reagent has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." the customer is fully operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2023-00051 was filed on 08-feb-2023.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® MASS CREATINE KINASE MB ISOENZYME (MMB) FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: helen bouchard ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 16326994
• Report Number: 2517506-2023-00051
• Device Sequence Number: 15057685
• Product Code: JHY
• UDI-Device Identifier: 00842768013829
• UDI-Public: 00842768013829
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K970343
• 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): 02/23/2023

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: 07/28/2023
• Device Model Number: 10444904
• Device Catalogue Number: SMN 10444904
• Device Lot Number: GB3209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/29/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2022
• 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 Age: 62 YR
• Patient Sex: Male