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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range and no instrument errors occurred at the time of the event.The customer did not observe any issues with probe dispense.The probes were not leaking or bent.The disinfectant tubings were in their correct containers.Wash solution bottles were full and new.Siemens is investigating the issue.

Event Description

A discordant, falsely low d-dimer result was obtained on a patient sample using the d-dimer low protocol on a bcs xp system using innovance d-dimer reagent.The discordant result was reported to the physician(s).Three other doubtful d-dimer results were obtained on this bcs xp system, which were not reported to the physician(s).The sample was repeated for d-dimer using the d-dimer low protocol on an alternate bcs xp system, recovering higher.The sample was repeated again using the d-dimer high protocol on the alternate bcs xp system, also recovering higher.This result was reported, as the correct result, to the physician(s).A new sample from the same patient was then run for d-dimer on the same alternate bcs xp system using both the d-dimer low and d-dimer high protocols.The results matched the previous results obtained on the alternate bcs xp system.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low d-dimer result.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2021-00038 on 12-apr-2021.Additional information (28-apr-2021): quality controls (qc) for d-dimer recovered in range at the time of the event, but controls for two other assays (prothrombin time (pt) and partial thromboplastin time (ptt)) had recovered out of range at the time of the event.Qc for d-dimer, pt, and ptt recovered in range after performing several intensive washes, performing the weekly tube disinfection, and checking the probe dispense.Sample integrity was acceptable, and the patient was not taking any medications.No other samples were affected.An instrument issue cannot be ruled out as a potential cause of the event.Inadequate mixing or centrifugation of the sample, as well as other sample mishandling also cannot be ruled out 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: 11651585
• MDR Text Key: 262222023
• Report Number: 9610806-2021-00038
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR