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

Model Number BCS XP SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center (ccc) and reported that they obtained different activated partial thromboplastin time (aptt) results for a patient on the bcs xp system.Upon obtaining different results on the patient samples, the customer ran quality controls (qcs), resulting within expected ranges.As per the siemens technical solutions center (tsc) specialist's instructions, the customer ran a validation test, which recovered as expected.Since qc recovery and the validation test recovered within specification, the tsc specialist determined that there was no indication of a system or reagent malfunction.The customer declined further investigation and indicated that the sample draws were potentially mixed; this sample handling use error potentially contributed to the different results obtained on samples from the affected patient.The system and reagent are performing according to specifications.No further evaluation of these devices is required.

Event Description

Two samples (sample id (sid) (b)(4) and sid (b)(4)) from the same patient were run and repeated for activated partial thromboplastin time (aptt) on the bcs xp system using the dade actin fsl activated ptt reagent.The samples were identified with different types of sample barcodes and the aptt results obtained on sid (b)(4) did not match aptt results obtained on sid (b)(4).The initial results were reported to the pharmacist(s), who questioned the results as they observed differences in the results.These results were not used to monitor the patient's heparin therapy and the customer reported that the physician(s) stopped the patient's heparin drip.The correct aptt result for this patient is unknown as the patient was not redrawn to verify either result.There are no known reports of patient intervention or adverse health consequences due to the different aptt results obtained on samples from the patient.

• 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
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; am kronberger hang 3; registration number:3003601075; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7402591
• MDR Text Key: 105256329
• Report Number: 9610806-2018-00039
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1