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

Model Number BCS XP SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc); the customer asked which international sensitivity index (isi) value should be used on a laboratory information system (lis) when calculating international normalized ratio (inr) results.The customer reported that since (b)(6) 2019, they reported patient results using the incorrect isi result and indicated that they will gather patient results that were tested in that time period.On (b)(6) 2019, the customer provided the results in mdr 9610806-2019-00015.The cause of the event was a use error.There was no instrument malfunction.The customer is aware of the instrument's labelling.The customer corrected the isi value on the lis.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported that they used the incorrect international sensitivity index (isi) value in a non-siemens laboratory information system (lis) to calculate international normalized ratio (inr) results for multiple patient samples 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 for 3 weeks; as per the customer 26 patients (44 samples) were impacted by this issue.However, the customer did not identify which patients were impacted.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.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2019-00015 on 08- march-2019.Additional information (20-feb-2019): as per 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.Corrected information (14-march-2019): the initial mdr indicated that " as per the customer 26 patients (44 samples) were impacted by this issue".Upon further investigation, the number of impacted patient samples is 41.No further investigation is required.Mdrs 9610806-2019-00016, 9610806-2019-00017, 9610806-2019-00018, 9610806-2019-00019, 9610806-2019-00020, 9610806-2019-00021, 9610806-2019-00022, 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.

• 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: 8406029
• MDR Text Key: 140625475
• Report Number: 9610806-2019-00015
• 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: 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
• Device Operator: Health Professional
• Device Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1