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

Catalog Number 10459330

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating the cause of the multiple discordant patient sample results that were obtained on the bcs xp instrument (serial number (b)(4)).

Event Description

Multiple discordant patient sample results were obtained on the bcs xp instrument (serial number (b)(4)).Customer stated that 5-10 erroneous patient sample results were reported to the physician(s), however, the customer did not provide any data or test results.Some of the test results were questioned by the physician(s) and some corrected results were reported.In addition, the customer also stated that the reagent probe was not dispensing liquid and there was a clicking noise coming from underneath the reagent probe.There are no reports of patient intervention or adverse health consequences due to the discordant patient sample results.

Manufacturer Narrative

Additional manufacturer narrative information (03-july-2018): siemens has determined that the cause of the multiple discordant patient sample results generated on the bcs xp instrument (serial number (b)(4)) is unknown.No additional information was provided by the customer.

• Brand Name: BCS XP
• Type of Device: BCS XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil von behring strasse 76; marburg, 35041 ; GM 35041
• MDR Report Key: 7628837
• MDR Text Key: 112566045
• Report Number: 9610806-2018-00053
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1