MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP RUBELLA G (RUB G) ASSAY; RUBELLA G IMMUNOASSAY

Model Number N/A

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

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

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was sent to the customer site for system inspection.The cse replaced the base pump, reagent diluter, and reagent syringe valve while troubleshooting, and several samples were run with expected results.The customer has observed additional sample comparison results not matching when run in duplicate (actual results not provided).Siemens is investigating.

Event Description

A false positive advia centaur cp rubella g (rub g) result was obtained for a patient sample.The patient sample was sent to a reference laboratory (npl) and the rubella g result was non-reactive.In general, the customer performs duplicate testing of samples, and will report a result if they are the same.The non-reactive result from the reference laboratory was reported to the provided.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant rubella g result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00220 on 11/03/2017 for a false positive advia centaur cp rubella g (rub g) patient result.11/07/17 - additional information: a siemens customer service engineer (cse) returned to the customer site.The cse replaced the base sample dilutor, grey peri-pump, and checked precision that was acceptable.While there were multiple parts replaced by the cse while troubleshooting, the root cause is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR CP RUBELLA G (RUB G) ASSAY
• Type of Device: RUBELLA G IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole, MA 02032
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 7001357
• MDR Text Key: 91465043
• Report Number: 1219913-2017-00220
• Device Sequence Number: 1
• Product Code: LFX
• UDI-Device Identifier: 00630414201412
• UDI-Public: 00630414201412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003412
• 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,Followup
• Report Date: 12/01/2017

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 Expiration Date: 01/27/2018
• Device Model Number: N/A
• Device Catalogue Number: 10310283
• Device Lot Number: 068196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1