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

Model Number	DADE INNOVIN
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An united states customer contacted siemens customer care center to report discordant result that was obtained on one patient sample on the ca-660 instrument.The following conclusion is made from the troubleshooting performed by siemens healthineers: the discrepancy in pt inr result was traced back to an incorrect mnpt (mean normal prothrombin time) value used for the inr calculation.The customer confirmed that a value of 28.7 was mistakenly used instead of the correct 11.3.Once corrected, results aligned with the reference lab.The customer is operational.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Customer reported a falsely depressed pt inr (prothrombin time, international normalized ratio) result obtained on one patient sample measured with innovin on the ca-660 system compared to reference lab results.There are no known reports of patient intervention or adverse health consequences due to the discordant result.

• 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: monika bornmann ; emil-von-behring- str. 76; marburg 35041 ; GM 35041 ; 915121287564
• MDR Report Key: 22672984
• Report Number: 9610806-2025-00032
• Device Sequence Number: 7495757
• Product Code: GJS
• UDI-Device Identifier: 00630414023472
• UDI-Public: (01)00630414023472(10)564661E(17)270215
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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 Model Number: DADE INNOVIN
• Device Catalogue Number: 10873566
• Device Lot Number: 564661E
• 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: 07/15/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female