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

Model Number	N/A
Medical Device Problem Codes	Use of Device Problem (1670); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states customer contacted the siemens regional support center to report non-numeric, flagged, inr patient results and falsely elevated pt results were measured with dade innovin reagent on a sysmex cs-2500 instrument.The inr results were flagged with errors and per the cs-2500 instructions for use, instructed the customer to reanalyze the sample.Siemens evaluated this issue and provided the following conclusion: no general system, software or assay issue could be found within the provided system data.The customer is most likely facing a pre-analytical issue.The customer is operational.Cs-2500 dade innovin lot: 564660 is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.Note: dade innovin is marketed in the united states under material number: 10873566.The 510(k) numbered documented in section g4 is for this product.
Event or Problem Description
The customer obtained non-numeric, flagged, inr patient results and falsely elevated pt results measured with dade innovin reagent on a sysmex cs-2500 instrument.The customer manually calculated an inr result of 10.0 seconds and this result was reported to, and questioned by, the physician(s).The sample was repeated at another laboratory and an inr result of 2.3 seconds was obtained and reported, as the correct result, to the physician(s).A second sample from the patient was also tested on the initial instrument and results of pt 22.1 seconds, inr 2.02 seconds were obtained.There are no known reports of patient intervention or adverse health consequences due to this issue.

• 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: jennifer cacace ; 511 benedict ave.; tarrytown, NY 10591 ; 8024302902
• MDR Report Key: 20818238
• Report Number: 9610806-2024-00056
• Device Sequence Number: 18096185
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: (01)00842768003806(10)564660(17)270208
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K974343
• 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): 12/02/2024

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 Model Number: N/A
• Device Catalogue Number: 10445706
• Device Lot Number: 564660
• 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: 11/07/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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: 60 YR
• Patient Sex: Female