MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH COAGULATION FACTOR VIII DEFICIENT PLASMA; PLASMA, COAGULATION FACTOR DEFICIENT

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	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center to report a falsely elevated factor viii result on a sysmex cn-6000 instrument.Siemens evaluated the issue and provided the following conclusion: based on the available information, the cause of the discordant result is caused by a handling error (erroneous rule configured in the site's middleware).The customer is operational and the reported issue is resolved by routine troubleshooting.Sysmex factor viii lot 560836a is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.
Event or Problem Description
The customer reported the observation of a falsely elevated factor viii result on a sysmex cn-6000 system.The result was reported to the physician(s) who, based on the patient's severe hemophilia classification, questioned the result.There are no known reports of patient intervention or adverse health consequences due to the discordant factor viii result.

• Brand Name: COAGULATION FACTOR VIII DEFICIENT PLASMA
• Common Device Name: PLASMA, COAGULATION FACTOR DEFICIENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer Contact: jennifer cacace ; 511 benedict ave.; tarrytown, NY 10591 ; 8024302902
• MDR Report Key: 20211210
• Report Number: 9610806-2024-00034
• Device Sequence Number: 7801420
• Product Code: GJT
• UDI-Device Identifier: 00842768010996
• UDI-Public: (01)00842768010996(10)560863A(17)251025
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K924396
• 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
• Report Date (Section B): 09/13/2024

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: 10/25/2025
• Device Model Number: N/A
• Device Catalogue Number: 10446411
• Device Lot Number: 560863A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/13/2024
• Date Device Manufactured: 10/26/2023
• 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: 21 YR
• Patient Sex: Male