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

Model Number BCS XP SYSTEM

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) for the negative qc recovered low and out of range at the time of the event.The positive qc recovered in range, but borderline low.A siemens customer service engineer (cse) was dispatched to the customer site.The cse observed that the customer accidentally placed calcium chloride (cacl) in position 1 on the bcs xp system, instead of washing solution.The cse discarded the cacl bottles on the system.The cse placed a new cacl bottle on the system and placed new washing solution in position 1.Three pipettor washes were performed, after which qc was repeated, recovering in range.Patient samples were also rerun, recovering higher.The cause of the event is use error.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2021-00043 was filed for the discordant aptt results obtained on (b)(6) 2021 on the same bcs xp system.

Event Description

Discordant, falsely low activated partial thromboplastin time (aptt) results were obtained on multiple patient samples on a bcs xp system using pathromtin sl reagent.The discordant results were reported to the physician(s).A siemens customer service engineer (cse) observed that calcium chloride(cacl) was accidentally placed in position 1 on the bcs xp system, instead of washing solution.The calcium chloride (cacl) reagent in position 1 on the bcs xp system was replaced with washing solution, and the samples were repeated for aptt, recovering higher.The higher 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, falsely low activated partial thromboplastin time (aptt) 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, 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 11827129
• MDR Text Key: 262223224
• Report Number: 9610806-2021-00044
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• 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: 04/20/2021
• 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