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

Model Number BCS XP SYSTEM

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc) and reported that discordant "no clot" results were obtained on multiple patient samples, without further flags.A siemens field service engineer (fse) was dispatched to the customer's site.Siemens is investigating the issue.

Event Description

The customer reported that discordant activated partial thromboplastin time (aptt) results of "no clot" were obtained on multiple patient samples on the bcs xp system when the pathromtin sl reagent vial was empty.The discordant results were not reported to the physician(s).The samples were rerun on an alternate bcs xp system or on the same bcs xp system after replacing the reagent vial, resulting in correct aptt results.The correct aptt results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant "no clot" aptt results obtained on patient samples.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2018-00052 on 15-jun-2018.Additional information (28-may-2018): the initial mdr indicated that a siemens field service engineer (fse) was dispatched to the customer's site.During this visit, the fse inspected the system and determined that the belt tension transport belt rack feeder was low.The fse observed analysis errors: 210 (accumulated error message), 3027 (too large difference to the initial value), and 3028 (level above vessel edge).The customer indicated that they loaded reagent vials correctly in the racks.The fse cleaned and re-greased the linear guide x transfer arms, removed and cleaned the rack feeder, and tightened the straps of the belt tension conveyor belt.The fse also removed, cleaned and ground checked the rear rack platform, offset values of the rack coupler, checked offset values of scanner and tube sensor and ran quality controls, which recovered acceptably.Siemens further investigated the instrument data and observed unexpected behavior of reagent volume over time.The difference in volume, from the time in which the reagent was inserted until the time the reagent was ejected, was less than expected with the performed measurements using the reagent vial.Siemens determined that "no clot" results were obtained when the level sensor did not detect the decrease in reagent volume, when processing a sample.The cause of the discordant "no clot" aptt results obtained on patient samples is unknown.The samples were not rerun on an alternate bcs xp system.The samples were only rerun on the initial bcs xp system.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

The samples were not rerun on an alternate bcs xp system.The samples were only rerun on the initial bcs xp system.

• 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; am kronberger hang 3; registration number:3003601075; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7607975
• MDR Text Key: 111489988
• Report Number: 9610806-2018-00052
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2018
• 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