MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN

Model Number	DADE INNOVIN
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).After the discordant results were obtained, the customer repeated quality controls (qc) and a measurement error was obtained.The customer noticed that the dade innovin reagent was low and replenished the onboard reagent.The customer then repeated qc, which recovered in range.The customer then repeated the affected patient sample, and the results recovered correctly.A siemens customer service engineer (cse) was later dispatched to the customer site to investigate intermittent measurement errors on the system.The cse replaced the pump and realigned the probe.The system is operational post service visit.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) result were obtained on a patient sample on a sysmex ca-660 system using dade innovin reagent.The discordant results were reported to the physician(s).The sample was then repeated two times for pt and inr, recovering lower.The lower 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, falsely low pt and inr results.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 14595326
• Report Number: 9610806-2022-00040
• Device Sequence Number: 13952338
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/03/2022

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: 05/27/2024
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown