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

Model Number	DADE INNOVIN
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely low prothrombin time international normalized ratio (inr) result was obtained on a patient sample on a sysmex ca-1500 system (serial number: (b)(4)) using dade innovin reagent (lot number: 549701).Siemens further investigated the issue and was unable to determine the cause of the discordant result.Quality controls (qc) were in range and there were no issues with other patient samples, indicating that the issue was likely sample specific.Siemens was unable to rule out inadequate mixing of the sample or other preanalytical variables.Inadequate mixing can lead to discordant results due to both uneven anticoagulant dispersal and possible fibrin strand formation.Remixing of the sample can then produce acceptable recovery.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low prothrombin time international normalized ratio (inr) result was obtained on a patient sample on a sysmex ca-1500 system (serial number: (b)(4)) using dade innovin reagent (lot number: 549701).The discordant result was reported to the physician(s), and the result was questioned by the physician(s).The same sample was repeated for inr on the same instrument with the same reagent, resulting higher.The customer then ran a precision study on the instrument, and all results recovered within range.The customer then remixed and respun the same patient sample and repeated it again for inr using the same system and reagent, also resulting higher and confirming the initial repeat.The two repeat results were reported, as the correct results, to the physician(s).There are no known reports of medical intervention or adverse health consequences due to the discordant, falsely low inr result.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg d-35041, ; GM
• MDR Report Key: 8732289
• Report Number: 9610806-2019-00059
• Device Sequence Number: 2021874
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K974343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

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: 11/24/2019
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1