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

Model Number	BCS XP SYSTEM
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) for prothrombin time (pt) were flagged and did not recover in range, but qc for all other assays recovered in range at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.No optic issues were reported by the cse.The cse found that the sample syringe secure mount was loose.The cse secured the sample syringe.The cse then ran the bcs xp validation kit, which failed the sample wet system validation test.The cse then replaced the sample probe and reran the validation kit, which recovered within specifications.Qc was then run and recovered in range.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, prothrombin time (pt), prothrombin time international normalized ratio (inr), activated partial thromboplastin time (aptt), and d-dimer results were obtained on multiple patient samples on a bcs xp system.Some of the results were flagged with "absorbance too high" and "optical system exceeded the measuring range" errors, but the flagged results were not identified.No discordant results were reported to the physician(s).The delay in patient testing was mitigated as the customer had an alternate bcs xp system to process the samples.There are no reports of patient intervention or adverse health consequences due to the discordant results or the delay in patient testing.

• 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: 11426850
• Report Number: 9610806-2021-00024
• Device Sequence Number: 2854593
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K970431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1