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

Model Number	BCS XP SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer contacted a siemens customer care center (ccc) regarding a discordant, falsely elevated activated partial thromboplastin time (aptt) result on one patient sample on the bcs xp system.Siemens reviewed the files that were provided by the customer and determined that there was no indication of a reagent malfunction.The customer ran a validation kit (pathromtin sl lot 536708b) on a bcs xp system (serial number (sn): (b)(4)) and samples (b)(6) failed while all the other samples passed.The same kit was used on another bcs xp system (sn: 121591) and validation passed.The customer repeated the validation with a new kit, different reagent lot, with fresh water on the first bcs xp system and experienced the same failures.A customer service engineer (cse) was dispatched to the customer site and replaced the sample probe and the sample wash station.The cse verified performance of the system and observed that the system was working within specifications, and all quality control levels were within specification.The discordant, falsely elevated activated partial thromboplastin time (aptt) result was potentially due to debris occluding the sample probe from the sample wash station.No further issues have been observed after the sample probe and the wash station were replaced.The system is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
After failing a validation kit test on a bcs xp system, the customer repeated previously run patient samples and determined that a discordant, falsely elevated activated partial thromboplastin time (aptt) result using pathromtin sl reagent lot 536708b on a bcs xp system (serial number (sn): (b)(4)) was reported to the physician(s).The same patient sample was repeated on a second bcs xp system (sn: (b)(4)) and resulted lower.The customer stated that the pathologist reviewed the initial and repeat results and concluded that the obtained results were not significant because the patient had subsequent lab work done every 5 hours.There are no reports of patient intervention nor adverse health consequences due to the discordant, falsely elevated aptt results.

• Brand Name: BCS XP SYSTEM
• Common Device Name: 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: 8708760
• Report Number: 9610806-2019-00057
• Device Sequence Number: 11217892
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K970431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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 Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1