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

Model Number BCS XP SYSTEM

Device Problem High Test Results (2457)

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

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that two discordant, falsely elevated prothrombin time international normalized ratio (inr) results were obtained on a patient sample on a bcs xp system using dade innovin reagent.Siemens investigated the bcs xp system log files that were sent by the customer.Quality controls (qc) recovered within range on the day the two discordant inr results were obtained.The first reaction kinetic had a no coagulation error with a flat line reaction kinetic and did not produce a result.The volume curve for the reagent showed no volume decrease for this measurement, which is why there was no reaction.The reason why there was no reagent transfer could not be determined, and it appears to be a single issue.The reaction kinetics of the following two discordant inr results were normal and the inr results were evaluated correctly.The volume for the sample as well as for the reagent correctly correlate with the amount of sample and reagent volume used to obtain these two inr results.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2019-00065 was also filed for additional discordant inr results for samples from the same patient.

Event Description

Two discordant, falsely elevated prothrombin time international normalized ratio (inr) results were obtained on a patient sample on a bcs xp system using dade innovin reagent.The discordant results were reported to the physician(s).The patient had been undergoing oral anticoagulation therapy (oat); however, two days prior, based on two other discordant, falsely elevated inr results, the physician(s) suspended the patient's oat.The physician questioned the two new discordant, falsely elevated inr results.The patient was redrawn and retested for inr using a non-siemens analyzer, resulting lower.This result was reported, as the correct result, to the physician(s).There are no reports of adverse health consequences due to the discontinuation of the patient's oat based on the discordant, falsely elevated 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-350 41; GM D-35041
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; registration number: 300360107; am kronberger hang 3; schwalbach,
• Manufacturer Contact: christopher aebig ; siemens healthcare diagnostics; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 8901989
• MDR Text Key: 159790993
• Report Number: 9610806-2019-00066
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• 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: 07/23/2019
• 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
• Patient Age: 90 YR