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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The customer reported that they calculated the affected patients' prothrombin time (pt) international normalized ratio (inr) results with the international sensitivity index (isi) value in the table of assigned values (tav); this is acceptable when the pt inr calculation is intended to be performed on the bcs xp system.However, the customer calculated the pt inr results on a non-siemens laboratory information system (lis); as per a siemens communication to customers in december of 2012, when customers rollover to a dade innovin reagent lot, customers are instructed to contact the siemens technical solutions center to obtain the correct isi to be updated in the lis.The customer indicated that they are aware of this communication, contacted siemens, and siemens provided a letter to the customer (dated 15-jan-2019) with the correct isi value to use for their dade innovin reagent lot (549722).As per siemens instructions, the customer updated the isi result in their lis.Siemens further investigated the issue and determined that there was no instrument or reagent malfunction; the bcs xp system evaluated the results correctly and the results were correctly transmitted to the lis.A use error contributed to the incorrect pt inr results.The system is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2019-00015_s1, 9610806-2019-00016, 9610806-2019-00017, 9610806-2019-00018, 9610806-2019-00019, 9610806-2019-00020, 9610806-2019-00021, 9610806-2019-00023, 9610806-2019-00024, 9610806-2019-00025, 9610806-2019-00026, 9610806-2019-00027, 9610806-2019-00028, 9610806-2019-00029, 9610806-2019-00030, 9610806-2019-00031, 9610806-2019-00032, 9610806-2019-00033, 9610806-2019-00034, 9610806-2019-00035, and 9610806-2019-00036 were filed for the same issue.
Event or Problem Description
The customer reported that they've used the incorrect international sensitivity index (isi) value in a non-siemens laboratory information system (lis) to calculate international normalized ratio (inr) results after the samples were processed correctly on a bcs xp system.The customer used the isi value of 0.93 to calculate patient samples' inr results instead of the isi value of 1.09.The customer indicated that since (b)(6) 2019, they reported patients' inr results using the incorrect isi value daily for 3 weeks.As per the customer, 26 patients (41 samples) were impacted by this issue.The customer did not identify which patients were impacted nor the dates of testing.The patient's inr results were recalculated using the correct isi value.The correct inr results were reported to the physician(s).There was no report of patient intervention or adverse health consequences due to the customer using the incorrect international sensitivity index (isi) value to calculate inr results for patient samples.

• 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: 8433114
• Report Number: 9610806-2019-00022
• Device Sequence Number: 19145793
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/19/2019

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: 02/20/2019
• Initial Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1