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 Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that they obtained a discordant, falsely low unfractionated (uf) heparin result on a patient sample on the bcs xp system, using a non-siemens reagent.The customer reported that quality controls (qcs) were within expected ranges on the day of the event and that the issue is isolated to one patient sample.A siemens customer service engineer (cse) was dispatched to the customer's site and the cse determined that there was no indication of an instrument malfunction when the discordant result was obtained on the patient sample.There were neither error codes nor error conditions, on the affected bcs xp system, that were related to this issue at the time of the event.During this visit, the cse: cleaned the optics read window; adjusted the reference channel; verified all optics settings and values; repeated the affected sample; ran qcs.The qcs recovered acceptably and the results obtained on the affected sample were repeatedly <0.00 iu/ml.The cse replaced the flash lamp and repeated the sample; the same result (<0.00 iu/ml) was obtained on the patient sample.Then, the cse reinstalled the previous flash lamp and the customer recalibrated the heparin assay.The affected sample was repeated after the customer recalibrated the assay, resulting in the same result.The use of the non-siemens' reagent on the siemens' bcs xp system is a user defined method and not validated by siemens.The cause of the discordant, falsely low uf heparin result is unknown.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely low unfractionated (uf) heparin result was obtained on a patient sample on a bcs xp system, using a non-siemens reagent.The discordant result was reported to the physician(s).The sample was repeated on an alternate bcs xp system using the non-siemens reagent, resulting higher.The repeat result was reported, as the correct result, to the physician(s).The sample was also repeated on (b)(6) 2018 on the alternate bcs xp system and on (b)(6) 2018 on the initial bcs xp system for troubleshooting purposes; the results obtained on the sample on the initial system were 0.00 iu/ml.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low uf heparin result.

Manufacturer Narrative

The initial mdr indicates that the initial sample was also repeated on (b)(6) 2018 for troubleshooting purposes.The customer clarified that on (b)(6) 2018, the patient was redrawn twice and the samples were tested on the alternate bcs xp system, resulting in unfractionated (uf) heparin results of 0.06 iu/ml and 0.09 iu/ml; these results were reported to the physician(s).Both samples were repeated on the affected bcs xp system with serial number (b)(4) and results of 0.00 iu/ml were obtained.Additional information (04-oct-2018): the patient was on tissue plasminogen activator (tpa), which the physician(s) stopped to start administering heparin, when samples from the patient were tested for uf heparin.The customer discovered that the patient was not on uf heparin when these samples were drawn and determined that none of the results obtained on the samples were discordant.On (b)(6) 2018, the physician(s) switched the patient's treatment to low molecular weight heparin (lmwh).The customer provided the sample ids for the samples that were tested on (b)(6) 2018.Siemens further investigated the results obtained for samples from this patient and verified that the variation in results between the bcs xp systems were clinically acceptable.The difference in uf heparin results was related to a sample specific issue.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

An unfractionated (uf) heparin result of <0.0 iu/ml was obtained on a patient sample, using a non-siemens reagent, on a bcs xp system.The result of <0.0 iu/ml was reported to the physician(s).The sample was repeated on an alternate bcs xp system using the non-siemens reagent, resulting higher.The repeat result was reported to the physician(s).On (b)(6) 2018, the patient was redrawn twice and both samples were run on the alternate bcs xp system and on (b)(6) 2018, the samples were repeated on the initial bcs xp system.Uf heparin results of 0.00 iu/ml were obtained on the initial bcs xp system, while higher results were obtained using the alternate system.The results obtained on the redrawn samples on (b)(6) 2018 were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the different uf heparin 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
• MDR Report Key: 7926547
• MDR Text Key: 122808550
• Report Number: 9610806-2018-00101
• 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: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 10/04/2018
• Supplement Dates FDA Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1