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 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).A siemens customer service engineer has been dispatched to the customer site to perform a precision study using the customer's bcs xp system and innovance heparin reagent.Siemens is investigating the issue.

Event Description

One discordant falsely elevated and four discordant falsely low heparin results were obtained on a patient sample on a bcs xp system using a non-siemens assay.The sample was also repeated once more for heparin on the bcs xp system using innovance heparin reagent, resulting falsely low.The discordant results were not reported to the physician(s).The correct heparin result for this patient was reported to physician(s), but it is unknown which system and reagent were used to obtain the correct result.One discordant falsely elevated and two discordant falsely low heparin results were also obtained on a patient sample from a different patient on the same bcs xp system using a non-siemens assay.The sample was repeated a fourth time for heparin on the bcs xp system using a non-siemens assay, generating the correct result which was reported to the physician(s).The sample was also repeated once more for heparin on the bcs xp system using innovance heparin reagent, resulting falsely low.None of the discordant results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant heparin results.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2021-00001 on 05-jan-2021.Additional information (19-jan-2021): quality controls (qc) run using the innovance heparin reagent recovered in range at the time of the event.However, some of the qc run with the non-siemens assay did not recover in range at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site and ran a precision study using the non-siemens assay, which performed acceptably.Siemens cannot rule out pre-analytical factors such as sample integrity issues or interferences due to patient medication as potential causes of the event.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• 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
• MDR Report Key: 11117949
• MDR Text Key: 225126734
• Report Number: 9610806-2021-00001
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (y/n): N
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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: 10459330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1