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

Catalog Number	10445705
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics inc.Has investigated the provided information to determine the cause of the discordant high prothrombin time (pt)/ international normalized ratio (inr) patient result generated on the sysmex ca-620 analyzer.No product non-conformance nor system issue could be identified.A potential cause of the event may be due to sample handling or the nature of the sample.The cause of the discordant high prothrombin time (pt)/ international normalized ratio (inr) patient result generated on the sysmex ca-620 analyzer is unknown.The instrument and reagent are performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant high prothrombin time (pt)/international normalized ratio (inr) patient result (pt extended >160 seconds / inr >16.0) was generated on a sysmex ca-620 analyzer and reported to the physician.The physician did not question the result.Pt quality control (qc) was within range at the time of testing.The patient was sent to the emergency department and a redraw sample was tested on a sysmex ca-1500 analyzer at the hospital lab.This pt/inr patient result (pt 20.7/ inr 2.0) was within the therapeutic range for anticoagulant therapy and reported to the physician.The patient did not receive any additional treatment and was discharged.The customer repeated the original patient sample the next day (after remix/re-centrifugation) on the same sysmex ca-620 analyser and a lower pt/inr result was generated (pt 14.4/inr 1.47).This result was not reported to the physician.There are no reports of patient intervention or adverse health consequences due to the discordant high pt/inr patient result.

• Brand Name: DADE INNOVIN
• Common Device Name: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• MDR Report Key: 7233793
• Report Number: 9610806-2018-00020
• Device Sequence Number: 1823556
• Product Code: GJS
• UDI-Device Identifier: 00842768003790
• UDI-Public: 00842768003790
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/01/2018

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: 11/17/2018
• Device Catalogue Number: 10445705
• Device Lot Number: 539373A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR