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

Catalog Number B4212-50

Device Problem Use of Device Problem (1670)

Patient Problem Cancer (3262)

Event Date 10/29/2015

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.Manufacturer's preliminary analysis: samples have been measured at the alternative wavelength of 570 nm which is indicative for sample peculiarities that prevented valid measurements at the regular wavelength of 405nm.The 405nm measurements provided error flags as follows: result questionable; the optical system exceeded the measuring range; minimum absorbance too high; and no plateau.The kinetics of the 570 nm measurements show partially high absorbance values which are typical for lipemic or hemolytic samples (as also indicated by the clinical chemistry result reports) and are in line with an automatic switch by the bcs xp instrument from the regular 405 nm to the alternative 570nm wavelength.However, some results obtained at 570 nm have not been flagged.Qc measurements are within acceptance ranges and are not indicative of any potential performance limitation of the instrument or reagent.We have no indications for a potentially systemic instrument or reagent issue and we have no similar complaints from other customers.It is possible that the observed discrepant results are caused by sample specific peculiarities from this patient.Samples from the patient are not available for internal investigations.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

Falsely elevated prothrombin time (pt%) results were obtained on patient samples on the bcs xp instrument.The patient results were reported to the physician.It is unknown if patient treatment was altered or prescribed on the basis of the falsely elevated pt% results.The patient subsequently died due to organ collapse.

Manufacturer Narrative

Siemens healthcare diagnostics inc.Filed the initial mdr (9610806-2015-00070) on november 23, 2015.Supplement filed to add c&rr number 2432235-01/08/2016-001-c.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: 5242315
• MDR Text Key: 31803303
• Report Number: 9610806-2015-00070
• 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: Physician
• 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

• Date FDA Received: 11/23/2015
• 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
• Date Manufacturer Received: 01/08/2016
• 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
• Patient Age: 43 YR