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

Model Number	BCS XP SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range at the time of the event.No instrument errors occurred at the time of the event and no other patients were affected.Shipping and testing of this specific patient's samples is not feasible due to limitations of sample stability for coagulation testing.Interferences from patient medications or diagnosis, as well as inadequate mixing or other mishandling of the sample cannot be excluded as potential causes of the discordant results.The cause of the discordant, falsely elevated prothrombin time and prothrombin time international normalized ratio results cannot be determined.The system is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00025 was filed for the discordant pt and inr results obtained on (b)(6) 2020.
Event or Problem Description
A discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) result were obtained on a patient sample on a bcs xp system using dade innovin reagent.The discordant results were obtained from automatic repeats of pt and inr after a "no reaction" error was initially generated by the system.The discordant results were reported to the physician(s) and were questioned.The patient was told to skip his next coumadin dose due to the high results.A second sample from the same patient was run later the same day for pt and inr, resulting lower.These results were also reported to the physician(s).The following day, another sample from the same patient was run for pt and inr, resulting lower.These results were reported, as the correct results, to the physician(s).The customer then repeated the original sample from the previous day for pt and inr.A "no reaction" error was generated and the sample was automatically repeated for pt and inr, both recovering falsely elevated.The other sample from the previous day was also repeated for pt and inr, recovering falsely elevated and matching the results obtained for this sample from the previous day.There are no reports of adverse health consequences due to the falsely elevated pt and inr results.

• 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: 10134639
• Report Number: 9610806-2020-00024
• Device Sequence Number: 19629156
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 06/09/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR