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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event and no instrument errors were observed.For sample id (b)(6), the correct results were obtained after recentrifuging the sample, indicating the sample may not have been centrifuged properly.For sample id (b)(6), the initial high aptt result could also indicate incomplete centrifugation.Improper centrifugation as well as issues regarding the integrity of the sample collection tubes used cannot be ruled out as potential causes of the event.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2021-00020 and 9610806-2021-00021 were filed for additional discordant results obtained on (b)(6) 2021 and (b)(6) 2021 on the same bcs xp system.

Event Description

Discordant, falsely elevated and falsely low activated partial thromboplastin time (aptt) results were obtained on two different patient samples on a bcs xp system using pathromtin sl reagent.Discordant, falsely elevated prothrombin time (pt) and prothrombin time international normalized ratio (inr) results were obtained on one of the two patient samples on a bcs xp system using dade innovin reagent.The discordant results were not reported to the physician(s).The samples were repeated for the respective assay and the correct repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant activated partial thromboplastin time (aptt), prothrombin time (pt), and prothrombin time international normalized ratio (inr) results.

• 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; registration number: 300360107; am kronberger hang 3; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 11382344
• MDR Text Key: 234506218
• Report Number: 9610806-2021-00019
• Device Sequence Number: 1
• Product Code: GKP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• 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: 10470625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2021
• 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