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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event, no instrument errors occurred, and the event was limited to patient samples from one patient.Siemens received feedback that the customer did not properly follow the laboratory's policy for handling sample flags.Additionally, pre-analytical issues such as improper sample collection and handling cannot be ruled out.The customer has re-educated the users on proper handling of sample flags.The cause of the event is use error.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00065 was also filed for the discordant results obtained on (b)(6) 2020.

Event Description

Discordant, falsely elevated and falsely low activated partial thromboplastin time (aptt) results were obtained on three patient samples from the same patient measured on a bcs xp system using actin fsl reagent.Prior to being run on the bcs xp system, each of the samples was run for aptt on a sysmex cs-5100 system.No numerical results were generated on the sysmex cs-5100 system.When run for aptt on the bcs xp system, each of the samples gave a falsely low result with a "doubtful flag" on the first run.On the second run, the first sample gave a falsely low aptt result, the second sample gave a falsely elevated aptt result, and the third sample did not give a numerical result and generated a "curve without reaction" error.On the third run, the first sample gave a falsely elevated aptt result, the second sample gave a falsely low aptt result, and the third sample gave a falsely low aptt result.A falsely low aptt result was reported to the physician(s) who questioned the result.A corrected report was issued but it is unknown which result was reported in the corrected report.Several days later, a new sample from the same patient was measured, recovering acceptably.

• 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, 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 11003026
• MDR Text Key: 221274279
• Report Number: 9610806-2020-00064
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• 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