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 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Siemens reviewed the backup files provided by the customer.The provided backup showed that the reagent arm no longer absorbs enough reagent when the reagent bottle becomes empty (at the last possible pipetting), causing a discordant result.The issue may be related to the reagent rack movement, as the reagent rack position can affect reagent level sensing.Siemens is investigating the issue.

Event Description

A discordant, falsely elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample on a bcs xp system.The discordant result was not reported to the physician(s).The same sample was repeated for aptt on the same system, resulting lower.This result was considered to be the correct result.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated activated partial thromboplastin time (aptt) result.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2020-00014 on 04-may-2020.Siemens filed the first supplemental mdr 9610806-2020-00014_s1 on 05-may-2020.Additional information (23-apr-2020): a siemens customer service engineer (cse) was dispatched to the customer site to service the customer's bcs xp system.The rack lanes in the cooling area were cleaned by the cse.The rack platform of the cooling area was not level.This was corrected by a mechanical adjustment and verified by a plausibility check of the support software.Adjustment of the y-offset and z-delay of the rack were found to be acceptable.Mechanical adjustment of the rack coupler was within tolerance.The pulleys of the rack transport belt required cleaning and lubrication.The movement and automatic insertion of the racks into the cooling unit was checked and found to be acceptable.The system was functional upon the cse's departure.The cause of the issue cannot be determined.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00015_s2 was filed for the same issue.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2020-00014 on 04-may-2020.Additional information (04-may-2020): mdr 9610806-2020-00015 was filed for an additional discordant, falsely elevated activated partial thromboplastin time (aptt) result obtained with the same bcs xp system on (b)(6) 2020.

• 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: 10021583
• MDR Text Key: 191181431
• Report Number: 9610806-2020-00014
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• 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: 10461894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR