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	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center to report incorrect pt patient sample results being reported on a sysmex cs-2500 system.Siemens could not rule out mishandling of the dade innovin reagent.Quality controls (qc) were run prior to patient samples being run and the results were in range.The operator log indicates a change/add reagent operation for dade innovin reagent took place at 03:17 am on the day in question, also prior to the samples being run.The log file does not indicate qc was performed after this operation.It could not be ruled out that a new vial of dade innovin reagent had been added to the sysmex cs-2500 system at this time and was used for patient testing without qc being performed first.The customer has auto qc set to run every 8 hours; however, vial qc is not turned on, therefore addition of a new reagent would not have triggered qc to run automatically.The original patient samples were repeated on an alternate sysmex cs-2500 system and yielded expected results.A potential product issue has not been identified.The customer is operational.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely low prothrombin time (pt) results were obtained on 12 patient samples on a sysmex cs-2500 system using the dade innovin reagent.The discordant results were reported to the physician(s).Quality controls had been run prior to processing of patient samples and results were within specification.The physician questioned the reported result for one patient who was reported to be receiving coumadin treatment.Therefore, all samples from between 5:00 am and 7:00 am were repeated on an alternate sysmex cs-2500 system resulting higher, and these results were reported as correct.The patient sample that was initially questioned, was also repeated on the original sysmex cs-2500 system after adjustments were made and the result agreed with the repeat testing performed.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low pt 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
• MDR Report Key: 9187087
• Report Number: 9610806-2019-00075
• Device Sequence Number: 2460218
• Product Code: GJS
• UDI-Device Identifier: 00630414023489
• UDI-Public: 00630414023489
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 10/14/2019

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: 02/22/2021
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873567
• Device Lot Number: 549740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1