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

Model Number	BCS XP SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely low heparin result was obtained on a patient sample on a bcs xp system.A siemens customer service engineer (cse) was dispatched to the site.The cse replaced the sample probe, the syringes, and the dilutor.The issue was isolated to one sample and no instrument errors occurred at the time of the event.Quality controls recovered within range at the time of the event.Possible causes of the event include a bubble in the system or the sample or improper mixing of the anticoagulant and the sample in the tube.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely low heparin result was obtained on a patient sample on a bcs xp system.The discordant result was reported to the physician(s).The patient was admitted to the hospital based on the reported result and was administered low molecular weight heparin (lovenox).The next day the physician questioned the result and requested that the sample be repeated for heparin.The original sample was repeated twice for heparin, resulting higher.These results were reported, as the correct results, to the physician(s).There are no reports of adverse health consequences due to the patient being administered lovenox as a result of the discordant, falsely low heparin result.
Additional Manufacturer Narrative
Siemens filed the initial mdr on 27-jan-2020.Additional information (30-jan-2020): siemens investigated the issue regarding the discordant, falsely low heparin result obtained on a patient sample on a bcs xp system.Quality controls (qc) recovered within range at the time of the event.There were no instrument errors and no other patient results were affected, indicating that the issue is sample specific.Siemens is unable to exclude sample collection and handling, if platelet poor plasma was used or if the sample had froth, lamellae or a bubble present.Additionally, the customer did not follow the recommendation in the bcs xp innovance heparin application sheet to check the sample and measure the sample again when a result of 0.00 iu/ml is obtained.The cause of the discordant, falsely low heparin result is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: BCS XP SYSTEM
• Common Device Name: 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: 9632274
• Report Number: 9610806-2020-00002
• Device Sequence Number: 380287
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K970431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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
• Operator of Device: Health Professional
• Device Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1