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

Model Number BCS XP SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.A siemens customer service engineer (cse) was dispatched to the customer's site.During this visit, the customer service engineer noticed the optics were out of range, and replaced the xenon lamp.Siemens determined that the error-log analysis showed that level errors were triggered at the time of the event for both pipettors.Siemens further investigated the issue and discovered that the control measurement after bottle change setting was not activated by the customer within the reagent definition on this instrument.Siemens determined that the customer did not run quality controls (qc) after replacing the dade innovin reagent vial prior to running patient samples.The next dade innovin reagent vial loaded by the customer was checked with qc, and the qc were within acceptable ranges.The cause of the discordant results was due to a use error, as the customer did not run qc prior to running patient samples, as recommended in the dade innovin reagent instructions for use.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

Discordant, falsely low prothrombin time percent (pt%) results and discordant, falsely elevated prothrombin time international normalized ratio (inr) results were obtained on multiple patient samples on a bcs xp system using the dade innovin reagent.The discordant results were reported to the physician(s), and the results were questioned by the physician(s).The samples were repeated on the same system after the customer loaded a new bottle of reagent, resulting in higher pt% and lower inr results.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant pt% and pt inr results.

• 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-35041, ; GM
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; am kronberger hang 3; registration number:3003601075; schwalbach, ; GM
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 8448936
• MDR Text Key: 139743074
• Report Number: 9610806-2019-00038
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• 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: 10461894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1