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

Model Number	DADE INNOVIN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The operator indicated that the affected patient sample was drawn in the correct tube for processing on the sysmex ca-1500 system and that the affected sample was neither lipemic, hemolytic nor icteric.The affected sample tube was correctly filled and the sample was centrifuged properly.A sample handing or collection issue potentially contributed to the discordant, falsely elevated prothrombin time (pt) result on the sysmex ca-1500 system.No other samples were affected by this event.Based on the sysmex ca-1500 system operator's manual, the probable cause of error "err999 analysis failed" is "an error in analysis action occurred in the instrument during analysis of the sample." based on the same operator's manual, the probable cause of error "err032 no coagulation" is "the coagulation reaction was not detected.Coagulation activity of the sample is low; fibrinogen concentration of the sample is low; the buffer is cool; the status of the sample and the reagent has some problem" and the probable cause of error "sample probe sampling error" is "amount of plasma is insufficient; inside diameter of tube or sample cup is too small; sample pipetting syringe is faulty." siemens healthcare diagnostics (siemens) is investigating the issue.
Event or Problem Description
A flagged, non-numerical prothrombin time (pt) result of "err999 analysis failed" and "sample probe sampling error" was obtained on a patient sample on the sysmex ca-1500 system.The same sample was rerun on the same system, resulting in another non-numerical flagged result of "err032 no coagulation".The same sample was repeated on the same system, resulting in a discordant, falsely elevated pt result.This result was reported to the nurse, who questioned the result as the patient was not on coumadin medication.The patient's blood was redrawn and run on an alternate sysmex ca-1500 system, using the same reagent lot, resulting lower.The initial sample was rerun on the alternate system, resulting lower.The repeat result of 10.7 seconds was provided to the physician as a correction to the discordant result.The results obtained on the alternate system aligned with the patient's clinical history.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated pt result.
Additional Manufacturer Narrative
Siemens healthcare diagnostics (siemens) filed the initial mdr 9610806-2017-00155 on 28-dec-2017.Additional information (28-dec-2017): the affected sample was not available for further investigation.Additional information (03-jan-2018): the affected sample id is (b)(6).Additional information (12-jan-2018): the operator provided the error log file of the sysmex ca-1500 system and the error log file demonstrates that the "sample probe sampling error" was triggered on (b)(6) 2017.A siemens headquarters support center (hsc) specialist reviewed the event to determine the cause of the discordant, falsely elevated prothrombin time (pt) result.Since the operator obtained a lower pt result when they reran the sample, the hsc specialist determined that the discordant, falsely elevated result was not reproducible.The hsc specialist concluded that the presence of clots in the sample, a sample integrity issue or inadequate aspiration of the sample, from the primary tube, potentially contributed to the flags and discordant result obtained on the sample.The cause of the event is unknown.The system and reagent are performing according to specifications.No further evaluation of this system or reagent is required.

• 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: 7152260
• Report Number: 9610806-2017-00155
• Device Sequence Number: 13824262
• Product Code: GJS
• UDI-Device Identifier: 00842768003806
• UDI-Public: 00842768003806
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: 08/07/2019
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10445706
• Device Lot Number: 539392
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1