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	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.(siemens) discussed the event with the customer to determine the cause of the discordant prothrombin time (pt) result reported on the patient sample from the sysmex ca-620 system.The customer indicated that internal quality controls were within range prior to and after running the patient sample on the sysmex ca-620 system.The customer also stated that they did not have any hardware errors in the logbook.Based on the ca series measurement evaluation and check method scientific bulletin (included with the analyzer at installation), when the operator obtains error 32: no coagulation, the operator should check sample integrity, verify delivery of sample and reagent and reanalyze the sample.If error persists, the operator should use an alternate method to confirm the data.The bulletin advises the customer against reporting results without numerical values.Siemens advised the customer to not report non-numerical results and that the error does not always signify a truly high pt result.There are many factors that may contribute to this error.Siemens also inform the customer about proper sample collection and that they should check for sample integrity.The customer considers the issue to be sample specific and informed siemens that she will educate her coworkers on how to handle error codes.The cause of the event is user error.The system and reagent are performing according to specifications.No further evaluation of the system or reagent is required.
Event or Problem Description
A flagged prothrombin time (pt) result was obtained on a patient sample on the sysmex ca-620 system.The customer reported this result as >170 seconds and notified the clinic that the sample will be retested at an alternate facility.The physician did not question the result.The customer checked the sample integrity and checked the sample for clots.The customer indicated that the patient sample was neither lipemic, hemolyzed, nor icteric and re-spun the sample.The customer aliquoted the sample into two sample cups and sent a sample cup to an alternate facility.At the alternate facility, the sample was rerun on an alternate sysmex ca-500 system and an alternate sysmex ca-600 system, resulting lower than the reported result.The other sample cup was rerun on the initial sysmex ca-620 system, resulting lower than the reported result.A corrected report with results obtained at the alternate facility was provided to the physician.The corrected results matched 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 reported on the patient sample.

• 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: 7006189
• Report Number: 9610806-2017-00131
• Device Sequence Number: 16511333
• Product Code: GJS
• UDI-Device Identifier: 00630414023472
• UDI-Public: 00630414023472
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 11/07/2017

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: 10/13/2019
• Device Model Number: DADE INNOVIN
• Device Catalogue Number: 10873566
• Device Lot Number: 539397D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1