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

Catalog Number	10445706
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated pt (prothrombin time) inr (international normalized ratio) and sec (seconds) results obtained on a patient sample measured with dade innovin on the ca-660 instrument.The erroneous results were not reported to the physician(s).The sample was repeated on the same instrument the repeat results were lower than the erroneous 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 this discordant falsely elevated pt inr and sec results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report the observation of a discordant high pt inr result for one patient sample on a ca-660 instrument.Quality control results were within acceptable ranges on the day of testing.Siemens is investigating.Note: dade innovin is marketed in the united states under material number 10873567.The 510(k) numbered documented in section g4 is for this product.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2026-00007 on 20-mar-2026.Additional information received on 18-may-2026: siemens reviewed the information provided and data obtained.Based on the review of information provided in the complaint, the probable cause of discordant pt (prothrombin time) inr (international normalized ratio) and sec (seconds) results for one patient tested with dade innovin lot 564665 on ca-660 instrument could not be identified.No other discordant results were obtained for the method with other patients and quality control results were within acceptable ranges on the day of testing.A historical review of the reagent lot involved did not reveal any similar complaints.Therefore, there is no indication of a reagent- or lot-specific problem.The customer is operational.The instrument is performing according to specifications.No further evaluation of this device is required.Section h6 has been updated to reflect updated investigation findings and investigation conclusion codes.

• 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: jana boensch ; emil-von-behring-str. 76; marburg 35041 ; GM 35041 ; 915204870918
• MDR Report Key: 24646948
• Report Number: 9610806-2026-00007
• Device Sequence Number: 18588448
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: (01)00842768003806(10)564665C(17)270613
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/21/2026

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: 564665C
• 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: 02/21/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2023
• 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: 23 YR
• Patient Sex: Female