MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM

Model Number BCS XP SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc.(siemens) headquarters support center (hsc) specialist reviewed the backup files from the affected bcs xp system to determine the cause of the potentially discordant, falsely elevated coagulation factor ix results obtained on the patient sample and determined that the issue is isolated to one specific patient.The discrepancy in results between different methods was observed for this patient prior to this incident.Raw values of quality controls (qcs) are available in the backup files provided by the customer and calibration was performed on (b)(6) 2017 and repeated on (b)(6) 2017 with the same reagent materials on the affected bcs xp system.Compared to the previous calibration using alternate lot numbers, the current lot combination demonstrated a decrease in raw value recovery.However, the hsc specialist determined that the qc recovery was within the ranges specified in the tables of assigned value(s).Different factor ix (fix) recombinant and/or modified supplements react differently with different manufacturer's activated partial thromboplastin time (aptt) reagents.This potentially contributed to the varying coagulation factor ix results obtained on the patient samples between the different systems and reagents.The coagulation factor ix assay was run with the dade actin fsl activated ptt reagent (actin fsl reagent) on the bcs xp system and actin fsl reagent does not have a known bias leading to false results with any fix concentrates.The cause of the event is unknown.Three samples from this patient were run or repeated on a bcs xp system (either on the bcs xp system with serial (b)(4), the bcs xp system with sn (b)(4) or both) across four days ((b)(6) 2017).The customer did not provide all of the results obtained on these patient samples and from the back up files, the hsc specialist determined that there is not a remarkable difference in the raw values obtained on the samples from this patient.The systems and reagents are performing according to specifications.No further evaluation of these systems or reagent is required.Sample (b)(6) was run on (b)(6) 2017 on the bcs xp system with sn (b)(4) and mdr 9610806-2017-00142 was filed for these discordant results.(b)(6) (under (b)(6)) and (b)(6) were run on (b)(6) 2017 on the bcs xp system with sn (b)(4) and mdr 9610806-2017-00140 were filed for these discordant results.(b)(6) was rerun on (b)(6) 2017 on the bcs xp system with sn (b)(4) and mdr 9610806-2017-00144 was filed for these discordant results.(b)(6) was run on (b)(6) 2017 on the bcs xp system with sn (b)(4) and mdr 9610806-2017-00141 was filed for these discordant results.

Event Description

On (b)(6) 2017, potentially discordant, falsely elevated coagulation factor ix results were obtained on a patient sample on the bcs xp system.None of the results obtained on the bcs xp system were reported to the physician.On (b)(6) 2017, a sample from the same patient was run on an alternate non-siemens (stago) system and resulted lower.It is unknown if the sample run on (b)(6) 2017 on the bcs xp system was the same sample that was run on (b)(6) 2017 on the stago system.The customer indicated to the physician that different results were obtained on samples from this patient between the stago system and the bcs xp system.The customer also indicated that a sample from this patient was run using an alternate (beckman il) reagent and the results recovered similar to the results obtained on the bcs xp system.The correct coagulation factor ix result for this patient is unknown.Even though the physician indicated that the coagulation factor ix result obtained on the stago system was more plausible, the physician does not have confidence in any of the results obtained on samples from this patient.The customer indicated that the patient was tested for coagulation factor ix on both the stago system and bcs xp system prior to and after receiving factor ix (fix) concentrate treatment.The customer indicated that they observed a better change in results (28% to 150%) on the stago system compared to the change in results that they observed on the bcs xp system after the patient received fix concentrate treatment.There are no known reports of patient intervention or adverse health consequences due to the potentially discordant, falsely elevated coagulation factor ix results.

Manufacturer Narrative

Siemens healthcare diagnostics (siemens) filed the initial mdr 9610806-2017-00143 on 07-dec-2017.Additional information (02-jan-2018): the patient was administered alprolix and benefix, coagulation factor ix (recombinant), at the time of the event.Additional information (02-jan-2018): the operator indicated that factor sensitivity studies were performed prior to implementation of the dade actin fsl activated ptt reagent lot.A siemens healthcare diagnostics inc.(siemens) headquarters support center (hsc) specialist further analyzed the event to determine the cause of the potentially discordant coagulation factor ix results.The hsc specialist determined that there was no indication that a reagent or instrument issue contributed to the event.The hsc specialist determined that the difference in results was expected for a patient under alprolix medication.The alprolix manufacturer's instruction for use (ifu) indicates: "to confirm adequate factor ix levels have been achieved and maintained, monitor patient plasma factor ix levels by performing a validated one-stage clotting assay [see dosage and administration (2.1)].Factor ix results can be affected by the type of aptt reagent used.Measurement with a one-stage clotting assay using a kaolin-based aptt reagent has been shown to result in an underestimation of factor ix levels." benefix manufacturer instructs: "monitor patients for factor ix activity levels by the one-stage clotting assay to confirm that adequate factor ix levels have been achieved and maintained, when clinically indicated." siemens's dade actin fsl activated ptt reagent is an ellagic acid based aptt reagent, while stago's ck prest is a kaolin based aptt reagent.Mdr 9610806-2017-00140_s1, mdr 9610806-2017-00141_s1, mdr 9610806-2017-00142_s1, and mdr 9610806-2017-00144_s1 were filed for the same event.

• Brand Name: BCS XP SYSTEM
• Type of Device: BCS XP SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7097496
• MDR Text Key: 95738330
• Report Number: 9610806-2017-00143
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (y/n): N
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1