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

Catalog Number B4212-50

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

The cause of the discrepant falsely elevated pt% results is unknown.Root cause investigation has been initiated and is ongoing.Siemens healthcare diagnostics is continuing to investigate the issue with the customer.Siemens will provide an update to this report if additional information becomes available.

Event Description

A falsely elevated, unflagged prothrombin time (pt%) result was obtained on a patient sample on the bcs xp instrument.It is unknown if the patient result was reported to the physician.It is unknown if patient treatment was altered or prescribed on the basis of the falsely elevated pt% result.There is no report of adverse outcome to the patient as a result of the falsely elevated pt% result.

Manufacturer Narrative

Siemens healthcare diagnostics inc.Filed the initial mdr (9610806-2015-00075) on december 29, 2015.Supplement filed to add c&rr number 2432235-01/08/2016-001-c to report and provide detail in the report.Siemens healthcare diagnostics has observed that in very rare cases false short clotting times for pt on bcs and bcs xp with dade innovin can occur.In such instances, false low pt inr values are obtained.These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients.The corresponding reaction curves of these rare samples showed a pre-peak, which can lead to falsely short clotting times.In rare cases the result was not flagged by the existing check algorithms.Under the conditions that there is an interference, there is a potential to miss a prolonged prothrombin time.In the majority of these situations the patient is either being intensively monitored or has a clinically apparent condition such as jaundice which would point to a reduction in hepatic clotting factor synthesis.Siemens issued an urgent medical device correction ph16-003.A.Us dated january 14, 2016 to u.S.Customers identified as using a siemens bcs/bcs xp automated blood coagulation analyzer in their laboratory and using dade innovin for a pt screening assay.The communication reemphasized the importance of checking the interference levels given in the respective application sheets of the bcs and bcs xp systems, as such an effect can occur in turbid, hemolytic or icteric samples from intensive care patients.Siemens is working on an advanced algorithm to identify these curves, which will be implemented after completion of all validation activities.

• Brand Name: DADE INNOVIN
• Type of Device: DADE INNOVIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 35041 ; GM 35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5331588
• MDR Text Key: 34586681
• Report Number: 9610806-2015-00075
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K974343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Medical Technologist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/08/2016

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
• Device Operator: Medical Technologist
• Device Expiration Date: 01/18/2018
• Device Catalogue Number: B4212-50
• Device Lot Number: 539337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2432235-01/08/2016-001-C
• Patient Sequence Number: 1