MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BATROXOBIN REAGENT; BOTHROPS ATROX REAGENT

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	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens regional support center (rsc) to report a falsely depressed batroxobin time (bxt) result on a sysmex cn-6000 instrument.Per the limitations section of the batroxobin instructions for use (ifu): "results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings." siemens evaluated this issue and provided the following conclusion: reagent issues were ruled out based on review of quality control (qc) results which showed recovery within acceptable ranges and no issues were reported with other patient samples.In addition, an assessment of instrument performance included a review of backup data files.Based on the available information, the cause of the discordant result is consistent with a sample integrity issue.The customer is operational, and the reported issue is resolved by routine troubleshooting.Sysmex cn-6000 batroxobin lot 509792 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 depressed batroxobin time (bxt) result on a sysmex cn-6000 system.The initial result was not reported to the physician(s).The customer repeated the test and the repeat results were higher then the initial result.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant batroxobin time (bxt) result.

• Brand Name: BATROXOBIN REAGENT
• Common Device Name: BOTHROPS ATROX REAGENT
• 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: 20146341
• Report Number: 9610806-2024-00033
• Device Sequence Number: 4209693
• Product Code: JCO
• UDI-Device Identifier: 00842768011504
• UDI-Public: (01)00842768011504(10)509792(17)260327
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K932787
• 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): 09/05/2024

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: 03/27/2026
• Device Model Number: N/A
• Device Catalogue Number: 10446463
• Device Lot Number: 509792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 03/28/2024
• 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 Age: 29 YR
• Patient Sex: Male