MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN; TEST, TIME, PROTHROMBIN

Catalog Number	10445706
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens customer care center to report discordant high results that were obtained on five patient samples on the cn-3000 instrument.Siemens is investigating.Note: dade innovin is marketed in the united states under material number 10873566.The 510(k) number documented in section g4 is for this product.
Event or Problem Description
The customer reported the observation of discordant increased pt (prothrombin time) inr (international normalized ratio) results obtained on five patient samples measured with dade innovin on the cn-3000 instrument compared to repeat testing.It is unknown whether patient results were reported to the physician.Patient sample testing was repeated as quality control results were out of range and invalidated the initial run.There are no known reports of patient intervention or adverse health consequences due to this discordant results.
Additional Manufacturer Narrative
Siemens filed the initial mda 9610806-2025-00035 on 2025-09-03.Additional information 2025-09-30: investigation result: the information provided was reviewed.Based on the data analysis the issue is deemed to be a single event, rather than a systemic issue related to the cn series or the reagents, based on the following observations: the issue was limited to a single reagent vial.After replacing it with a new vial, there is no information that the issue has recurred.No abnormalities related to the issue were detected on the device side.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DADE INNOVIN
• Common Device Name: TEST, TIME, PROTHROMBIN
• 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: michael bloecher ; emil-von-behring-str. 76; marburg 35041 ; GM 35041 ; 915201593313
• MDR Report Key: 22949724
• Report Number: 9610806-2025-00035
• Device Sequence Number: 9868184
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: (01)00842768003806(10)564664B(17)270411
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K974343
• 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): 10/06/2025

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 Catalogue Number: 10445706
• Device Lot Number: 564664B
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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