MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BERICHROM ANTITHROMBIN III (A); ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
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 depressed berichrom atiii patient result on a sysmex cs-5100 instrument.Siemens evaluated the issue and provided the following conclusion: based on the available information, no general software, assay or system issue could be identified.The issue was resolved by routine troubleshooting.Sysmex cs-5100 berichrom atiii 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 a falsely depressed berichrom antithrombin iii (berichrom atiii) result that was obtained on a sysmex cs-5100 instrument.The initial result was report to and questioned by the physician(s).The sample was repeated on an alternate sysmex cs-5100 and the repeat result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed berichrom atiii result.

• Brand Name: BERICHROM ANTITHROMBIN III (A)
• Common Device Name: ANTITHROMBIN III, TWO STAGE CLOTTING TIME ASSAY
• 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: 20505783
• Report Number: 9610806-2024-00042
• Device Sequence Number: 12859540
• Product Code: JPE
• UDI-Device Identifier: 00842768013461
• UDI-Public: (01)00842768013461(10)02557(17)251107
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K933125
• 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): 10/22/2024

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: 11/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 10446672
• Device Lot Number: 02557
• 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: 10/02/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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: 14 YR
• Patient Sex: Female