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 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center regarding discordant, falsely low pt% (prothrombin time) and falsely high pt inr (international normalized ratio) results obtained on patient samples on a bcs xp system.A service representative inspected the instrument, adjusted optics and tested in isp (instrument support program).The wet system and temperatures were checked.The service representative exchanged syringes, revised and adjusted the diluter mechanism.Validation and control measurements were carried out acceptably.Precision measurement with control n and p 20-fold determination was successful.One of the original patient samples was repeated on the original bcs xp system (sn: (b)(4)) and yielded correct results.The customer is operational.The cause of the event is not known.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

Discordant, falsely low pt% (prothrombin time) and falsely high pt inr (international normalized ratio) results were obtained on three aliquots from one patient on a bcs xp system using the dade innovin reagent.The discordant results were reported to the physician(s).Of the initial taken aliquots more aliquots were created and frozen.One additional aliquot each were sent to another laboratory and tested on a sysmex cs-2100i system.The pt% results were higher while the pt inr results were lower, these results were reported as correct.One aliquot each were repeated on the original bcs xp system and the results matched what was initially reported.All results were reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low pt% and falsely high pt inr.

• 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: 9235286
• MDR Text Key: 175418171
• Report Number: 9610806-2019-00077
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• 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: 10/01/2019
• 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: 51 YR